BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

    MDR report key: 3703958 · Received March 27, 2014

    Report

    Report Number
    0009610622-2014-00143
    Event Type
    Injury
    Date Received
    March 27, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED VIA X-RAYS. THE NAIL AND BOTH BROKEN LOCKING SCREWS WERE CLASSIFIED AS PRIMARY PRODUCTS DURING INVESTIGATION. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR) FOR THE NAIL. THE NAIL WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. THE DHR FOR THE SCREWS WAS NOT REVIEWED BECAUSE THE LOT CODES WERE NOT PROVIDED. THE IMPLANTS WERE NOT AVAILABLE FOR INVESTIGATION; THE ROOT CAUSE COULD NOT BE DETERMINED. THE POSTOPERATIVE X-RAYS SHOW THAT THE NAIL IS WRONG INSERTED APPROX. 70° TWISTED TO INTENDED POSITION: THE PROXIMAL SCREWS ARE INSERTED POSTERIOR TOWARDS ANTERIOR (SHALL BE INSERTED LATERAL TOWARDS MEDIAL); THE DISTAL SCREWS ARE INSERTED ANTERIOR TOWARDS POSTERIOR (SHALL BE INSERTED LATERAL TOWARDS MEDIAL). THE PROXIMAL LOCKING SCREW, INSERTED IN THE THREADED OBLIQUE HOLE, IS NOT COMPLETELY INSERTED INTO THE NAIL HOLE AND STICKS OUT TOWARDS POSTERIOR. ALSO THE CHOSEN SCREW PLACEMENTS ARE NOT LIKE RECOMMENDED IN THE OPERATIVE TECHNIQUE. ADDITIONALLY BOTH DISTAL SCREWS ARE BROKEN, MOST LIKELY DUE TO WRONG NAIL INSERTION IN COMBINATION WITH HEAVY LOADS AND OBESITY. THE WRONG NAIL AND SCREW POSITION IS ATTRIBUTED TO AN ABNORMAL USE. MOST LIKELY THE USER WAS NOT TRAINED ON THE SYSTEM. THE IFU AND OPERATIVE TECHNIQUE DESCRIBES IN DETAIL THE CORRECT USAGE OF GTN NAILS AND SCREWS. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO PREVIOUS OR ACTUAL ACTIONS ARE IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF GTN NAIL, REVISED DUE TO NON-UNION AND HARDWARE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF GTN NAIL, REVISED DUE TO NON-UNION AND HARDWARE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180435 LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention