BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER F/SYNFIX-LR

    MDR report key: 3181098 · Received June 20, 2013

    Report

    Report Number
    8030965-2013-03754
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    April 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    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. 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. THE INVESTIGATION OF THE COMPLAINED SCREW DRIVERS SHOWS THAT THE STARDRIVE TIPS ARE BROKEN OFF. THE BROKEN SURFACES DO NOT SHOW ANY ANOMALIES WHAT INDICATES MATERIAL CONFORMITY AS WELL. WE CANNOT EXACTLY EVALUATE THE REASON FOR THIS BREAKAGE. WE SUPPOSE THAT SIMPLY TOO MUCH APPLIED MECHANICAL FORCE WELL BEYOND ITS CALCULATED DESIGN CAUSED THE BREAKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW DRIVER BROKE DURING THE OPERATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280032 SCRDRIVER F/SYNFIX-LR HXX SYNTHES GMBH 2819974

    Patients

    Seq Age Sex Outcome Treatment
    1