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Attention Operating Surgeon

IMPORTANT MEDICAL INFORMATION

WRIGHT MEDICAL

SALVATION™ FUSION SYSTEMS

(153910-1)

OUTLINE:
DEFINITIONS

I. GENERAL PRODUCT INFORMATION

PATIENT

SELECTION

CONTRAINDICATIONS

C. POTENTIAL COMPLICATIONS AND ADVERSE REACTIONS

PRECAUTIONS

E. MRI SAFETY INFORMATION

F. HANDLING AND STERILIZATION

STORAGE

CONDITIONS

II. SPECIFIC PRODUCT INFORMATION

SALVATION™ MIDFOOT RECONSTRUCTION SYSTEM

Содержание Salvation 153910-1

Страница 1: ...ogy Inc 1023 Cherry Road Memphis TN 38117 U S A For additional information and translations please contact the manufacturer or local distributor For additional languages visit our website www wright com Then click on the Prescribing Use option English en The following languages are included in this packet ...

Страница 2: ......

Страница 3: ...3910 1 OUTLINE DEFINITIONS I GENERAL PRODUCT INFORMATION A PATIENT SELECTION B CONTRAINDICATIONS C POTENTIAL COMPLICATIONS AND ADVERSE REACTIONS D PRECAUTIONS E MRI SAFETY INFORMATION F HANDLING AND STERILIZATION G STORAGE CONDITIONS II SPECIFIC PRODUCT INFORMATION A SALVATION MIDFOOT RECONSTRUCTION SYSTEM ...

Страница 4: ...hese symbols and abbreviations Table 1 Definitions of Symbols and Abbreviations Symbol Definition g Batch code h Catalog number D Do not re use Y Caution consult accompanying documents i Consult operating instructions H Use by l Temperature limitation p Keep dry Keep away from sunlight N Date of manufacture M Manufacturer ...

Страница 5: ... K Sterilized using radiation STERILE GAS Sterilized using gas plasma J Sterilized using aseptic processing techniques For prescription use only Abbreviation Material Ti Titanium Ti6Al4V Titanium Alloy CoCr Cobalt Chrome Alloy SS Stainless Steel UHMWPE Ultra High Molecular Weight Polyethylene ...

Страница 6: ...the potential for success The implants require careful seating and adequate bone support In selecting patients for surgery the following factors can be critical to the eventual success of the procedure 1 Patient s occupation or activity If the patient is involved in an occupation or activity which includes substantial lifting or muscle strain the resultant forces can cause failure of the fixation ...

Страница 7: ... system Adequate bone stock to receive implant Availability of post operative therapy Cooperative patient See Section II for specific product information B GENERAL SURGICAL CONTRAINDICATIONS Infection Physiclogically or psychologically inadequate patient Inadequate skin bone or neurovascular status Irreparable tendon system Possibility for conservative treatment Growing patients with open epiphyse...

Страница 8: ...dily response Embolism See Section II for specific product information D PRECAUTIONS Following the instructions for use provided in product literature can minimize the potential for complications or adverse reactions with any implant It is the responsibility of each surgeon using implants to consider the clinical and medical status of each patient and to be knowledgeable about all aspects of impla...

Страница 9: ... delayed union non union or failure of the implant Abnormal force loading and subsequent wear may be caused by Uncorrected instability Improperly sized implant Inadequate soft tissue support Implant malposition Excessive motion Uncorrected or recurrent deformity Patient misuse or overactivity Proper fixation at the time of surgery is critical to the success of the procedure Bone stock must be adeq...

Страница 10: ... implant Removal of the implant with fusion of the joint Clinical results depend on surgeon and technique pre operative and post operative care the implant patient pathology and daily activity It is important that surgeons obtain appropriate informed consent and discuss the potential for complications with each patient prior to surgery This may include a review of alternative non implant procedure...

Страница 11: ...etrieved device fragments including the following information a The material composition of the fragment if known b The size of the fragment if known c The location of the fragment d The potential mechanisms for injury e g migration infection e Procedures or treatments that should be avoided such as MRI exams in the case of metallic fragments This may help to reduce the possibility of a serious in...

Страница 12: ...ce many considerations to achieve the best result in individual patients IF EXCESSIVE LOADING CANNOT BE PREVENTED AN IMPLANT SHOULD NOT BE USED The main goal of surgery with this implant is to establish bony fusion Abnormal or excessive forces could lead to delayed union non union or failure of the implant Abnormal force loading and subsequent wear may be caused by Uncorrected instability Improper...

Страница 13: ...faces to minimize the potential for early fatigue failure If complications develop possible corrective procedures include Implant removal Synovectomy Bone grafting of cysts Replacement of the implant Removal of the implant with fusion of the joint Clinical results depend on surgeon and technique pre operative and post operative care the implant patient pathology and daily activity It is important ...

Страница 14: ...maged retain it to assist with Wright Medical Technology s analysis of the event Carefully consider and discuss with the patient if possible the risks and benefits of retrieving vs leaving the fragment in the patient Advise the patient of the nature and safety of unretrieved device fragments including the following information a The material composition of the fragment if known b The size of the f...

Страница 15: ...ic implants is a risk related to component geometry and material as well as the MR power duration and pulse sequence Since MR equipment is not standardized the severity and likelihood of occurrence of these adverse effects are unknown for these implants Since these devices have not been tested Wright cannot make a recommendation for the use of MRIs with these implants neither for safety considerat...

Страница 16: ... the reuse of these devices include but are not limited to significant degradation in device performance cross infection and contamination Implants provided non sterile should be processed according to the recommended parameters for instruments below INSTRUMENTS Surgical instruments and non sterile implants should be cleaned and sterilized according to the following parameters CLEANING 1 Disassemb...

Страница 17: ...with deionized reverse osmosis RO DI water 9 Sonicate for a minimum of 10 minutes in an enzymatic detergent solution prepared per manufacturer directions 10 Rinse thoroughly flush with RO DI water 11 Dry with a clean soft absorbent disposable cloth 12 Visually inspect for cleanliness All visible surfaces internal and external should be visually inspected If necessary re clean until it is visibly c...

Страница 18: ...act with hard objects that may cause damage These recommended instructions are consistent with AAMI ST79 Table 5 guidelines and have been developed and tested using specific equipment The recommended instructions provided above have been validated by Wright Medical It remains the responsibility of the processor to ensure that the processing is performed using appropriate equipment and materials an...

Страница 19: ...ion with a cross screw for rotational stability All implants are made from Ti6Al4V titanium alloy INDICATIONS The SALVATION Midfoot Reconstruction System is indicated for fracture fixation osteotomies reconstruction procedures non unions and fusions of bones in the foot and ankle including the metatarsals cuneiforms cuboid navicular calcaneus and talus specific examples include intramedullary medi...

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