BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX PIN ADAPTOR - SHORT HOFFMANN LRF FOR PIN Ø3-4-5-6MM

    MDR report key: 3933784 · Received July 15, 2014

    Report

    Report Number
    0008031020-2014-00317
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    KTT
    PMA / PMN Number
    K113327
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT HOFFMANN LRF APEX PIN ADAPTOR HAD A STRESS CRACK CORROSION ISSUE AFTER SURGERY CAN BE CONFIRMED. THE ROOT CAUSE OF THIS BREAKAGE HAS BEEN IDENTIFIED AS A DESIGN ISSUE (MATERIAL NOT RESISTANT ENOUGH TO CORROSION). THIS PROBLEM HAS BEEN IDENTIFIED AND IS ADDRESSED. A NEW MATERIAL WILL BE IMPLEMENTED AS THIS BREAKAGE IS DUE TO A DESIGN ISSUE, A CREDIT NOTE WILL BE DONE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    SHORT APEX PIN ADAPTOR SNAPPED. PATIENT HAD FRAME ON 3 MONTHS BEFORE IT SNAPPED.

    Description of Event or Problem · 1

    SHORT APEX PIN ADAPTOR SNAPPED. PATIENT HAD FRAME ON 3 MONTHS BEFORE IT SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412413 APEX PIN ADAPTOR - SHORT HOFFMANN LRF FOR PIN Ø3-4-5-6MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT STRYKER TRAUMA SELZACH Z12644

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention