BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 3003615 · Received February 28, 2013

    Report

    Report Number
    3003787298-2013-10037
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE DEVICE WAS RECEIVED IN 3 PIECES. MANUFACTURING VISUAL EVALUATION NOTED THE NEEDLE SHEARED OFF AT THE BASE OF THE SLIDER. PHYSICAL DIMENSIONAL VERIFICATION WAS FOUND IMPOSSIBLE DUE TO THE DAMAGE EXHIBITED BY THE NEEDLE SHEARED OFF MID THREAD. ALL OTHER FEATURES RELATED TO THIS COMPLAINT THAT COULD BE MEASURED DURING THIS EVALUATION MEET SPECIFICATION. PRODUCT DEVELOPMENT REVIEWED THE DESIGN, WHICH INDICATED IT'S APPROPRIATE FOR ITS' INTENDED FUNCTION. IT WAS DETERMINED THAT IT IS UNKNOWN HOW THE DEVICE WAS USED AND IF USAGE COULD HAVE CONTRIBUTED TO THE BREAKAGE. COMPLAINT HISTORY FOR BREAKAGE FALL UNDER THE ESTIMATED RISK LEVEL, THEREFORE, THE RISK IS ADEQUATELY ADDRESSED AND NOT INDICATIVE OF ANY TRENDS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE SURGEON WAS USING MODULAR FOOT, AS THE DEPTH GAUGE (319.006) SNAPPED OFF AT THE TIP, WHEN HE WAS ATTEMPTING TO MEASURE THE LENGTH OF THE SCREW. THERE WAS NO ABUSE OF THE DEPTH GAUGE PREVIOUS TO THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86595 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HTJ SYNTHES JENNERSVILLE 6602084

    Patients

    Seq Age Sex Outcome Treatment
    1