BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3 Ø11X380MM X 125°

    MDR report key: 3132245 · Received May 29, 2013

    Report

    Report Number
    0009610622-2013-00291
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    June 3, 2010
    Report Date
    May 2, 2013
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REVIEW OF MANUFACTURING DOCUMENTS REVEALED NO DEVIATION IN THE MANUFACTURING PROCESS. AS NO ITEM WAS RETURNED NO PHYSICAL EXAMINATION COULD BE CARRIED OUT. GENERAL ASPECTS: THE BROKEN IMPLANT IS A TEMPORARY IMPLANT WHICH INEVITABLY WILL BE SUBJECT OF A FATIGUE FRACTURE IF THE BIOMECHANICAL STRESSES ON THE IMPLANT ARE TOO HIGH OR NOT CONSIDERABLY REDUCED DURING THE PERIOD OF IMPLANTATION. DURING THIS PERIOD THERE IS A RACE BETWEEN BONY CONSOLIDATION / FRACTURE HEALING AND IMPLANT BREAKAGE AS NOTED IN THE LABELING OF THE PRODUCT. USUALLY A BREAKAGE IS CONTRIBUTED TO BY ONE OR MORE DEFICITS, E.G. INSUFFICIENT BONE HEALING, PRODUCT DAMAGE. GENERALLY THE RISK OF A BREAKAGE WILL INCREASE WITH THE INCREASE OF LOAD CYCLES AND LOAD LEVEL. ASPECTS REGARDING THE GAMMA3 NAIL: IN ORDER TO DEVELOP THE MOST SUITABLE IMPLANT FOR FRACTURE FIXATION AS INDICATED IN THIS CASE SEVERAL COMPREHENSIVE ANALYSES AND TEST CAMPAIGNS WERE CARRIED OUT. THOSE INCLUDED FATIGUE TESTS TO DETERMINE THE IMPLANT ENDURANCE UNDER SIMULATED PHYSIOLOGICAL LOAD CONDITIONS AND FINITE ELEMENT ANALYSIS TO DETERMINE THE MAXIMUM MECHANICAL STRESSES. MECHANICAL COMPARISONS WERE MADE TO OTHER FIXATION DEVICES WHICH REPRESENTED THE STATE OF THE ART BACK AT THE TIME OF THE GAMMA3 IMPLANT DEVELOPMENT. BASED ON ABOVE TESTS THE DESIGN OF THE GAMMA3 NAIL HAS BEEN OPTIMIZED IN SUCH A MANNER THAT THE NAIL CURRENTLY FITS AT THE BEST TO THE ANATOMY OF A HUMAN BODY AND ALSO CONSIDERS MINIMAL INVASIVE ASPECTS. [THE REQUIREMENTS OF COUNCIL DIRECTIVE 93/42/EEC WERE IMPLEMENTED] ASPECTS REGARDING THE AFFECTED NAIL: THE STRENGTH OF THE TITANIUM NAILS IS SETTLED IN THE LOCAL MATERIAL SPECIFICATION, WHICH IS BASED ON ASTM F 136. THIS REQUIREMENT HAS NOT BEEN CHANGED SINCE INTRODUCTION (PROVEN BY EXTERNAL EXAMINATION OF THE RAW MATERIAL FOR EACH MATERIAL LOT). UNTIL DATE NO BREAKAGE HAS BEEN REPORTED FOR THE PRODUCT IN QUESTION THAT WAS BASED ON DEVIATION IN MANUFACTURING OR MATERIAL. IN THIS CASE, REFERRING TO RECEIVED MEDICAL DOCUMENTS, THE NAIL BROKE AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 6 ¾ MONTHS. RESULTS OF RECOMMENDED REGULAR FOLLOW-UP EXAMINATION WERE NOT PROVIDED. IT COULD NOT BE DETERMINED WHETHER THE PATIENT HAD BEEN COMPLIANT TO THE SURGEON¿S POST-OPERATIVE INSTRUCTIONS. AS THE NAIL WAS NOT AVAILABLE IT COULD NOT BE DETERMINED IF THE NAIL HAD BEEN DAMAGED INTRA-OPERATIVELY. WITH AVAILABLE INFORMATION THE CASE IS ASSUMED TO BE PATIENT RELATED BECAUSE OF A CONFIRMED NON-UNION. NO FURTHER TECHNICAL STATEMENT WAS POSSIBLE. AS TO MISSING X-RAYS NO MEDICAL STATEMENT WAS POSSIBLE. BASED ON PRESENTED INFORMATION AND REFERRING TO THAT NO DEVIATION WAS FOUND IN THE MANUFACTURING DOCUMENTS A DEFICIENCY IN THE NAIL IN QUESTION WAS NOT VERIFIED. THE CASE WILL BE CLOSED AND WILL BE REOPENED WHEN SUBSTANTIVE INFORMATION OR THE ITEM(S) BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICES ARE NOT AVAILABLE DUE TO THE ONGOING LITIGATION. (B)(4): WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY SUBSEQUENT TO IMPLANTATION, THE INTRAMEDULLARY ROD FAILED, CAUSING PATIENT TO SUSTAIN INJURY TO THE LEFT LEG AND ITS RELATED ANATOMICAL STRUCTURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY SUBSEQUENT TO IMPLANTATION, THE INTRAMEDULLARY ROD FAILED, CAUSING PATIENT TO SUSTAIN INJURY TO THE LEFT LEG AND ITS RELATED ANATOMICAL STRUCTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234167 LONG NAIL KIT R2.0, TI, LEFT GAMMA3 Ø11X380MM X 125° IMPLANT HSB STRYKER TRAUMA KIEL K196531

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention