BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3 Ø11X180MM X 125°

    MDR report key: 3071114 · Received April 22, 2013

    Report

    Report Number
    0009610622-2013-00215
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. INTERNAL INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED DEVICES MATCHED THE REPORT AND THE EVENT WAS CONFIRMED. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE / HAZARD INDICATED THE ISSUE WAS WITHIN TOLERANCE, THEREFORE NO CORRECTIVE ACTIONS WERE DEEMED NECESSARY AT THIS TIME. NO MATERIAL OR MANUFACTURING FAULTS FOUND. SPIRALED SCRATCHES IN THE PLASTIC SAFETY RING WOULD IDENTIFY THAT THE RING MUST HAVE BEEN INSERTED INITIALLY INTO THE CORRESPONDING INTERNAL THREAD OF THE NAIL. AS THEY ARE MISSING WE CAN ASSURE THAT THE SCREW HAS NEVER BEEN PLACED AS INTENDED INTO THE NAIL. ANOTHER INDICATOR IS THE MISSING MARK AT THE TIP OF THE SET SCREW WHICH WOULD HAVE BEEN CAUSED BY SCREWING THE SET SCREW DOWN INTO THE GROOVE OF THE LAG SCREW. THUS THE DAMAGES ON THE THREAD OF THE SET SCREW WERE MOST LIKELY CAUSED BY OBLIQUE INSERTION DUE TO HEAVY CONTACT WITH THE NAIL HOLDING SCREW. FINALLY WHEN REACHING THE NAIL THE SET SCREW COULD NOT BE TURNED INTO THE CORRESPONDING THREAD DUE TO THE DAMAGES. THE EVENT WAS NOT CAUSED BY A DEFICIENCY OF A DEVICE BUT MOST LIKELY TO IMPROPER HANDLING DURING A SUB-OPTIMAL INTRA-OPERATIVE PROCEDURE. THE EVENT HAD NOT BEEN CAUSED BY ANY DEFICIENCY OF THE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE SET SCREW GOT STUCK IN THE PROXIMAL BODY OF THE NAIL AND WOULD NOT SEAT PROPERLY. IT WAS EXCHANGED FOR A NEW NAIL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE SET SCREW GOT STUCK IN THE PROXIMAL BODY OF THE NAIL AND WOULD NOT SEAT PROPERLY. IT WAS EXCHANGED FOR A NEW NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172291 TROCHANTERIC NAIL KIT, TI GAMMA3 Ø11X180MM X 125° IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K124305

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR