BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 2940466 · Received February 4, 2013

    Report

    Report Number
    3003787298-2013-00005
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 9, 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND (B)(4) FOUND ARE NOT RELEVANT TO THIS COMPLAINT CONDITION. NO OTHER ISSUES WERE FOUND DURING MANUFACTURE THAT ARE RELEVANT TO THIS COMPLAINT CONDITION. A MANUFACTURING EVALUATION WAS CONDUCTED. THE RETURNED PRODUCT IS COMPLETE AND IN GOOD OVERALL CONDITION. THE RETURNED PRODUCT WAS CHECKED DIMENSIONALLY AND FUNCTIONALLY AND PASSED. THERE ARE SMALL TOOL MARKS ON THE NEEDLE WHERE IT ATTACHES TO THE SLIDER. THESE MARKS ARE NOT ASSOCIATED WITH THE MANUFACTURE OF THIS PRODUCT. THIS EVALUATION FOUND NO LOOSE PARTS AND NOTHING THAT WOULD CAUSE AN INCORRECT MEASUREMENT.

    Description of Event or Problem · 1

    FACILITY STAFF RECEIVED A REPLACEMENT DEPTH GAUGE ABOUT A MONTH AGO ((B)(6) 2012) AND NOTICED UPON OPENING THE DEVICE THAT IT WAS NOT SITTING TOGETHER PROPERLY. WHEN THE STAFF TESTED THE DEPTH GAUGE THE SHAFT AND HANDLE WERE LOOSE. THE SHAFT SHOULD THREAD INTO THE HANDLE BUT THE SHAFT COULD NOT THREAD ALL THE WAY. THE DEPTH GAUGE WAS NOT MEASURING CORRECTLY, THE MEASUREMENTS WERE OFF ABOUT A MILLIMETER AND A HALF. THIS INCIDENT HAD NO PROCEDURE NOR PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46952 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS DEPTH GAUGE HTJ SYNTHES JENNERSVILLE 7102017

    Patients

    Seq Age Sex Outcome Treatment
    1