BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC F/K-WIRES Ø0.6-3.2 F/COMPACT AIR DRIV

    MDR report key: 4152168 · Received October 8, 2014

    Report

    Report Number
    8030965-2014-01418
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    August 1, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE COUPLING TOOL SIDE WAS WORN OUT. THIS WAS ATTRIBUTED TO FAULTY CARE AND MAINTENANCE. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE QUICK COUPLING FOR K-WIRE "IS NOT FIX WHEN DRILLING THE BONE". THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631133 QC F/K-WIRES Ø0.6-3.2 F/COMPACT AIR DRIV HWE SYNTHES GMBH 13450

    Patients

    Seq Age Sex Outcome Treatment
    1