BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM

    MDR report key: 3081454 · Received April 29, 2013

    Report

    Report Number
    0009610622-2013-00223
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 20, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REGARDING LOCKING SCREWS: BOTH LOCKING SCREWS ARE BROKEN IN HALF; THE BREAKAGE SURFACES INDICATE THAT BOTH SCREWS BROKE SPONTANEOUS DUE TO AN OVERLOAD. THE X-RAYS SHOW THAT THE SCREWS BROKE DUE TO A DISPLACED NAIL TO DISTAL. THE NAIL DISPLACEMENT WAS MOST LIKELY CAUSED BY HEAVY LOADS DUE TO FULL WEIGHT BEARING. IT¿S POSSIBLE THAT THE SCREWS BROKE PRIOR TO THE NAIL; IN THIS CASE THE DISTAL ANCHORING WAS NO LONGER GIVEN AND THIS ISSUE DID ALSO CONTRIBUTE TO THE NAIL BREAKAGE. IF THE SCREWS BROKE PRIOR COULD NOT BE DETERMINED DUE TO MISSING INFORMATION. A MORE PRECISE STATEMENT WAS NOT POSSIBLE BASED ON THE RETURNED PRODUCTS AND INFORMATION. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW.

    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

    IT WAS REPORTED THAT A PATIENT CAME IN WITH PAIN (LEFT SIDE) AND IT WAS OBSERVED THAT THE NAIL HAS BEEN BROKEN. SCREWS WERE ALSO BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT CAME IN WITH PAIN (LEFT SIDE) AND IT WAS OBSERVED THAT THE NAIL HAS BEEN BROKEN. SCREWS WERE ALSO BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185673 LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K542551

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention