BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITER 0.8NM W/AO/ASIF-QC

    MDR report key: 3242215 · Received July 23, 2013

    Report

    Report Number
    8030965-2013-04448
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION, WHICH WAS CARRIED OUT ON THE BASIS OF MANUFACTURING AND MATERIAL DOCUMENTS, SUGGESTS THAT THE PRESENT TORQUE WAS ESTABLISHED IN APRIL 2010 IN ACCORDANCE WITH THE SPECIFICATIONS. ALSO, THE REVIEW OF THE PRODUCT HISTORY HAS PRODUCED NO ABNORMALITIES. THE EXACT CAUSE OF THE DAMAGE COULD NOT BE ELICITED, BUT IT APPEARS THAT THE TORQUE WAS USED TO LOOSEN A SCREW, WHICH IS NOT AN INTENDED USE FOR THIS INSTRUMENT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: AN INSTRUMENT FELL APART. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342364 TORQUE LIMITER 0.8NM W/AO/ASIF-QC GEY SYNTHES GMBH SER.NO. 10117

    Patients

    Seq Age Sex Outcome Treatment
    1