BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.7MM & SMALL SCREWS

    MDR report key: 2993271 · Received March 7, 2013

    Report

    Report Number
    8030965-2013-00792
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    March 1, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. ACTUAL EVENT DATE NOT KNOWN. THE DEVICE WAS RETURNED BECAUSE IT WAS NOT WORKING CORRECTLY. THE PRODUCT WAS RECEIVED AT SERVICE AND REPAIR AND WAS FOUND TO HAVE A DAMAGED COMPONENT. SERVICE AND REPAIR WAS UNABLE TO REPAIR THE PRODUCT. THERE IS NO FURTHER INFORMATION AVAILABLE ON THIS EVENT. IF ANY OTHER INFORMATION IS RECEIVED THIS WILL BE REPORTED VIA A SUPPLEMENT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW REPORTED THE FOLLOWING: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    NOT WORKING CORRECTLY. PRODUCT WAS RECEIVED AT SERVICE AND REPAIR ON (B)(6) 2012, PRODUCT WAS UNREPAIRABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98076 DEPTH GAUGE FOR 2.7MM & SMALL SCREWS DEPTH GAUGE HTJ SYNTHES GMBH 3545665

    Patients

    Seq Age Sex Outcome Treatment
    1