Implants trauma Proximal Humeral Locking Plate Small

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...

1. Introduction P. 5 Preface P. 6 Screws P. 7 Properties P. 8 Indications & Contraindications P. 8 Proximal Humeral Locking Plate Small 2. Surgical Technique P. 10 Pre-operative patient preparation P. 10 Surgical Technique P. 11 Postoperative treatment P. 11 Explantation 3. Information P. 13 Locking P. 13 Dotize® P. 14 Order list P. 16 Reconditioning Manual P. 18 Notes

o Preface The Proximal Humeral Locking Plate Small enables the medical treatment of fractures in the joint area. The special feature of this implant is the free choice of screw placement. The user is able to set any desired screw in any hole (except oblong hole). Especially with complex fractures the free choice of screw angle (+/- 15°, see page 13) has advantages in the fracture treatment.

Cortical Screw, Locking, D=3.5mm, SH Spiral Drill, D=2.7mm, L=100mm, AO Connector Screwdriver, WS 2.5, self-holding sleeve Cortical Screw, D=3.5mm 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=180mm, AO Connector Screwdriver, WS 2.5, self-holding sleeve Guide Wire, Steel, D=2.0mm, L=228mm, TR

Properties Properties of the material: • 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 Anatomical plate design Optimal reconstruction of the joint Easy adjustment due to oblong hole Plate lengths: 3, 4-hole

Indications & Contraindications Indications: • Dislocated, unstable 2, 3 and 4-segment fractures of the humeral head • Valgus-impacted 4-segment fractures of the humeral head • Non-union of the humeral head Diaphyseal fractures of the humeral head Existing infections in the fracture zone and operation area Common situations that do not allow osteosynthesis Obesity Lack of patient compliance Proximal Humeral Locking Plate Small Fractures of the humeral head amount to 5% of all fractures and at least 45% of all humerus fractures. Whereas severe injuries with considerable trauma predominate in younger...

Surgical Technique

Pre-operative patient preparation • Beachchair position • Adjustable accesory table to support arm position • Fluoroscopy from the head end Surgical Technique • • • • • • • • • Deltopectoral access Raising the calotte fragment with reduction onto the shaft fragment (fig.1) Temporary fixation of the reduction using drill wires (fig.2) Position the humeral plate 5mm distal to the proximal end of the tuberculum majus and 10mm dorsal to the posterior edge of the intertubercular groove and fixation of the humeral head plate by means of a cortical screw in the sliding hole Fixation of the humeral head...

Postoperative treatment • Functionally as early as possible • If bone quality is bad, shoulder bandage for a maximum of 4 weeks • Passively and actively guided movement exercises 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 13).

o Locking Locking works because: ♦ Screw material (TiALV) is slightly harder than plate material (Titanium Grade 2) • Screw head forms thread into the plate (no cutting) Benefits: • ± 15° and Locking • No pre threading • No cold welding • No debris • You can re-set the screw up to 3 times Dotize Type II anodization • Layer thickness 60-200nm Different colors + Film becomes an interstitial part of the titanium Implant surface remains sensitive to: Chipping - No visible cosmetic effect Peeling Discoloration Anodization Type II leads to following benefits* • Oxygen and silicon absorbing...

Order list Humeral Head Plate, Small, 3-hole Humeral Head Plate, Small, 4-hole Cancellous Screw, locking, D=4.2mm, L=38mm, SH Cancellous Screw, locking, D=4.2mm, L=40mm, SH Cancellous Screw, locking, D=4.2mm, L=42mm, SH Cancellous Screw, locking, D=4.2mm, L=44mm, SH Cancellous Screw, locking, D=4.2mm, L=46mm, SH Cancellous Screw, locking, D=4.2mm, L=48mm, SH Cancellous Screw, locking, D=4.2mm, L=50mm, SH Cancellous Screw, locking, D=4.2mm, L=55mm, SH Cancellous Screw, locking, D=4.2mm, L=60mm, SH Cortical Screw, locking, D=3.5mm, L=24mm, SH Cortical Screw, locking, D=3.5mm, L=28mm, SH Cortical...

The information below should help you in reconditioning medical devices. IMPORTANT INDICATIONS FOR DOCTORS & OPERATING THEATRE PERSONNEL This instruction Leaflet refers to all supplied non-steriLe implants and all reusable instruments from I.T.S. GmbH. Detailed information for the identification of the product (such as system classification, cat. no.) can be found in the product identification code and/ or on the packaging label. Make sure that you are familiar with the possible application, combinability and correct handling of the product. Please note that product systems can undergo modifications...

Sterilisation with steam: Fractionated vacuum procedure (at least 3 pre-vacuum phases) Manual disinfection If a cleaning agent without a disinfectant effect is used, separate disinfection must be carried out after manual cleaning. (Order: Decontamination for staff protection, cleaning, disinfection). Equipment: Commercially available disinfectant authorised for use with medical products from the VAH list. Manufacturer's information, e.g. concerning concentration, temperature and exposure time should be followed. The steps described in the table above also apply. Drying See table above. Checking,...