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OL - Olecranon Locking Plate

OL - Olecranon Locking Plate
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OL - Olecranon Locking Plate

Product catalog summary
Introduction
The Olecranon Locking Plates System is designed to facilitate early functional postoperative treatment, offering advantages over traditional fracture treatments that may restrict mobility. The plates are anatomically preformed and can be adjusted with careful bending, though excessive bending near plate holes can lead to failure.

Implants and Materials
The plates are made of titanium, and the screws are composed of TiAl6V4 ELI, which enhances fatigue strength and reduces the risk of inflammation and allergies. Key features include multi-directional locking, anatomical contouring, and optimal joint surface reconstruction.

Indications and Contraindications
The system is indicated for all dislocated fractures of the olecranon. Contraindications include blood clotting issues, critical general condition, diabetes, soft tissue damage, obesity, pre-existing elbow arthrosis, and lack of patient compliance.

Surgical Technique
Pre-operative preparation involves general or plexus anesthesia, with the patient positioned supine or abdominally. Implantation requires careful exposure of fracture segments, using olecranon hook plates for single fragment fractures and K-wires for multi-fragment fractures.

Postoperative Treatment
Postoperative care includes applying an upper arm cast, physical therapy, and early functional therapy after suture removal. Implant removal is optional and should occur at least 1.5 years post-operation or after confirmed bone healing.

Technical Information
Dotize® anodization enhances implant surface characteristics, reducing inflammation risk and improving fatigue resistance. The locking mechanism allows for no pre-threading, reduced cold welding, and the ability to reset screws up to three times.

Reconditioning and Maintenance
Implants are single-use, while reusable instruments should be cleaned and sterilized according to specific guidelines to prevent damage. Steam sterilization is recommended, and instruments should be reconditioned promptly after use.

Specifications and Recommendations
The document details procedures for automatic cleaning and thermal disinfection of medical products using a Miele PG 8536 machine, validated according to EN ISO 15883 and ÖGSV guidelines. The recommended cleaning agent is Neodisher® Mediclean forte with a pH value of 9-11.

Automatic Cleaning Procedure
The process includes pre-rinsing with softened water, cleaning with purified water at 55°C, rinsing, thermal disinfection at 90°C, and drying at 110°C. Jointed instruments should be opened, and cannulated instruments connected to rinsing nozzles.

Manual Cleaning/Disinfection
Manual cleaning is discouraged unless necessary. Recommended agents include Sekusept® Aktiv 2% by ECOLAB. Instruments should be soaked, cleaned, and rinsed thoroughly, especially in hard-to-reach areas. Manual disinfection is required if the cleaning agent lacks disinfectant properties.

Inspection and Maintenance
Instruments must be inspected for cleanliness and functionality. Movable parts should be lubricated, and reassembly should be checked for ease.

Sterilization
Sterilization should be performed using the fractionated pre-vacuum procedure as per EN 285 and EN ISO 17665 standards. Instruments should be dismantled for effective sterilization.

Disposal and Responsibility
Hospitals are responsible for the disposal of instruments and must ensure proper cleaning and sterilization before returning products to I.T.S. GmbH.

Important Information
The instructions are validated for reconditioning medical devices. Routine inspections and validation of the process are necessary to ensure effectiveness.

Patient Information
Patients should be informed about post-implantation care and the importance of reporting any negative changes.

Symbols and Standards
The document includes symbols for prescription, single use, sterilization methods, and compliance with standards like ISO 13485 and ISO 17664.
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Catalog excerpts

OL - Olecranon Locking Plate-1

Implants trauma Olecranon Locking Plates System

 Open the catalog to page 1
OL - Olecranon Locking Plate-2

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a board certified physician. WARNING: If there is no sufficient bone healing, wrong or incomplete postoperative care, plate might break. All ITS plates are preformed anatomically as a matter of principle. If adjustment of the plate to the shape of the bone is required, this is possible by carefully bending gently in one direction once. Particular care is required when bending in the region of a plate hole, as deformation of the plate may lead to a failure of the locking mechanism. The plate must not be buckled or bent...

 Open the catalog to page 2
OL - Olecranon Locking Plate-3

1. Introduction P. 5 Preface P. 6 Screws P. 7 Properties P. 8 Indications & Contraindications P. 8 Time of operation 2. Surgical Technique P. 10 Pre-operative patient preparation P. 10 Access P. 11 Implantation P. 11 Implantation of single fragment fractures P. 13 Implantation of multi fragment fractures P. 15 Case studies P. 16 Postoperative treatment P. 16 Explantation 3. Information P. 17 Notes P. 19 Locking P. 19 Dotize® P. 20 Order list P. 22 Reconditioning Manual

 Open the catalog to page 3
OL - Olecranon Locking Plate-5

Preface The primary advantage of the locking olecranon plates lie in early functional postoperative treatment. Conventional fracture treatment with tension bands and subsequent immobilization can lead to heterotopic ossifications and subsequent limited mobility in the elbow.

 Open the catalog to page 5
OL - Olecranon Locking Plate-6

Cortical Screw, locking, D=3.5mm, SH Spiral Drill, D=2.7mm, L=100mm, AO Connector Screwdriver, WS 2.5, self-holding sleeve Spiral Drill, D=2.7mm, L=100mm, AO Connector Screwdriver, WS 2.5, self-holding sleeve Cancellous Screw, locking, D=4.2mm, SH Spiral Drill, D=2.5mm, L=110mm, AO Connector Screwdriver, WS 2.5, self-holding sleeve

 Open the catalog to page 6
OL - Olecranon Locking Plate-7

Properties Properties of the implant: • Plate material: Titanium • Material of screws: TiAl6V4 ELI • Easier removal of the implant after the fracture has healed • Improved fatigue strength of the implant • Reduced risk of cold welding • Reduced risk of inflammation and allergy • Multi-directional locking • Anatomically contoured • Optimal reconstruction of the joint surface • Simple positioning due to sliding hole Olecranon Hook Plate: Olecranon Plate: • Sliding hole with compression option up to 4mm • Lengths: 5-hole left/right 7, 9-hole left 7, 9-hole right • Lengths: 6, 8, 10, 12-hole • Long...

 Open the catalog to page 7
OL - Olecranon Locking Plate-8

Indications, Contraindications & Time of operation Indications: • All dislocated fractures of the olecranon General problems with blood clotting Critical general condition Diabetes Damage of soft tissue Obesity Pre-existing arthrosis of the elbow Lack of patient compliance Time of operation: • Primary on the first day after the trauma • Secondary after swelling subsides, temporary fixation in an upper arm plastercast or with an external fixing device

 Open the catalog to page 8
OL - Olecranon Locking Plate-9

Surgical Technique

 Open the catalog to page 9
OL - Olecranon Locking Plate-10

Pre-operative patient preparation • Under a general anaesthesia or plexus anaesthesia with pneumatic partial deprivation of blood supply • Supine position or abdominal position Access A slightly bow-shaped skin incision should be made in the radial direction, deviating from the ulnar edge, in order to create a soft tissue flap which will cover the plate. The scar should not extend directly above the plate. However, in individual cases, preexisting scars or deep abrasions can cause access to be changed.

 Open the catalog to page 10
OL - Olecranon Locking Plate-11

Implantation The bone is skillfully prepared with the scalpel. The fracture segments should be exposed as carefully as possible in order to not further decrease blood flow. The elbow joint should be radially exposed as far as necessary to enable a good view of the joint surface of the olecranon, and of the final reduction. Implantation of single fragment fractures Single fragment fractures can be reduced directly with the olecranon hook plate. It is implanted like a reduction hook and is initially screwed to the ulna in the sliding hole. When compression principle of the sliding hole is fully...

 Open the catalog to page 11
OL - Olecranon Locking Plate-12

The necessary remaining screws can then be inserted at a fixed angle, where required, in order to securely capture all parts of the fracture. The objective of operative treatment is to achieve stable fixation of the fragments. Olecranon Hook Plate Olecranon Plate

 Open the catalog to page 12
OL - Olecranon Locking Plate-13

Implantation of multi fragment fractures In the case of multi fragment fractures, K-wires can be used to temporarily fix intermediate fragments. Depending on the fracture, the sliding hole can initially be loosely engaged. The olecranon fragments can be inserted at a fixed angle before the main fracture is definitively fixed by tightening the screw in the sliding hole.

 Open the catalog to page 13
OL - Olecranon Locking Plate-14

The necessary remaining screws can then be inserted at a fixed angle, where required, in order to securely capture all parts of the fracture. The objective of operative treatment is to achieve stable fixation of the fragments.

 Open the catalog to page 14
OL - Olecranon Locking Plate-15

Case studies Case 1 - Olecranon Hook Plate: • Pre- and intraoperative radiographs following fixed angle fixation of a multi fragment fracture of the olecranon AO 21 B1. Case 1 - Olecranon Plate: • Pre- and intraoperative radiographs following fixed angle fixation of a fracture of the olecranon AO 21 A1.

 Open the catalog to page 15
OL - Olecranon Locking Plate-16

Postoperative treatment • Dependent on swelling and the condition of the soft tissue, application of an upper arm cast until wound is completely healed • Physical therapy • Free early functional therapy following removal of the sutures Explantation If desired by the patient, the implant can be removed. Removal should be performed at the earliest 1 1/2 years later or after radiographic verification of the healed bone. The problem of cold welding was resolved by using a special surface treatment (for further information see page 19).

 Open the catalog to page 16
OL - Olecranon Locking Plate-19

Locking Locking works because of: • Screw material (TiAlV) is slightly harder than plate material (Titanium Grade 2) • Screw head forms thread into the plate (no cutting) ± 15° and Locking No pre threading No cold welding No debris You can re-set the screw up to 3 times Dotize® Chemical process - anodization in a strong alkaline solution* Type III anodization Dotize Type II anodization + Film becomes an interstitial part of the titanium - Implant surface remains sensitive to: Chipping Peeling Discoloration Type - III - No visible cosmetic effect Dotize® Type - II Ti-Oxid Anodization Type II leads...

 Open the catalog to page 19

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.