BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM

    MDR report key: 3082659 · Received April 29, 2013

    Report

    Report Number
    0009610622-2013-00222
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 15, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032579
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND, NEITHER FOR THE GAMMA3 LONG NAIL NOR FOR THE LOCKING SCREW. THE EVALUATION REVEALED THAT THE LONG NAIL AS WELL AS THE 40MM LOCKING SCREW BROKE IN A FATIGUE FRACTURE DUE TO OVERLOAD. NO DISCREPANCIES WERE DETECTED DURING REVIEW OF RISK ANALYSIS. THE LOCKING SCREW WITH CAT. # 17965050S IS REGARDED AS CONCOMITANT PRODUCT, AND THE EVENT OF SCREW BREAKAGE HAS TO BE EXAMINED IN CORRELATION WITH THE BREAKAGE OF THE LONG NAIL KIT R2.0, STST, LEFT GAMMA3 Ø11X340MM X 125° WITH CAT. # 43250340S. THUS, THE EVENT IS REGARDED NOT DEVICE RELATED. DUE TO MISSING INFORMATION SUCH AS PERIOD OF IMPLANTATION, ANY PATIENT DATA AND - ANAMNESIS, X-RAYS PRE-, INTER- AND POSTOPERATIVE AS WELL AS SURGICAL RECORDS, SURGEONS¿ INSTRUCTIONS AND PATIENTS¿ ACTIVITY LEVEL A MORE PRECISE STATEMENT REGARDING THE ROOT CAUSE OF THE EVENT IS NOT POSSIBLE.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SURGEON REPORTED TO THE SALES REP, THAT "THE GAMMA 3 NAIL FRACTURED AND WAS EXPLANTED."

    Description of Event or Problem · 1

    THE SURGEON REPORTED TO THE SALES REP, THAT "THE GAMMA 3 NAIL FRACTURED AND WAS EXPLANTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183742 LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K121707

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention