BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELESCOPIC STRUT LONG HOFFMANN LRF LENGTH: 177-277MM (RED)

    MDR report key: 3840166 · Received May 30, 2014

    Report

    Report Number
    0008031020-2014-00265
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 8, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    KTT
    PMA / PMN Number
    K113327
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT OF ¿HARDWARE BREAKAGE¿ WAS CONFIRMED. UPON VISUAL INSPECTION OF THE DEVICE, IT WAS FOUND THAT THE BAJONET BOLT WAS BROKEN OFF. BASED ON THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED BROKEN BAJONET BOLT WAS ATTRIBUTED TO A USER RELATED ISSUE. IT WAS REPORTED THAT THE SURGEON USED PLIERS, WHICH WERE NOT PART OF THE HOFFMANN SYSTEM TO ADJUST THE STRUT. THE OPERATIVE TECHNIQUE INDICATES THAT THE STRUT SHOULD BE TIGHTENED BY HAND DURING LENGTHS ADJUSTMENTS, AND THERE ARE NO INSTRUMENTS OR PLIERS PROVIDED IN THE SYSTEM TO PERFORM THIS ACTION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE DETERMINED DURING THE INVESTIGATION.

    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 PATIENTS ANKLE WAS BEING REVISED DUE TO HARDWARE BREAKAGE.

    Description of Event or Problem · 1

    THE PATIENTS ANKLE WAS BEING REVISED DUE TO HARDWARE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317860 TELESCOPIC STRUT LONG HOFFMANN LRF LENGTH: 177-277MM (RED) APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT STRYKER TRAUMA SELZACH R16674

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention