BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC F/K-WIRES Ø0.6-3.2 F/532.001 532.010

    MDR report key: 4110166 · Received September 23, 2014

    Report

    Report Number
    8030965-2014-00885
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    March 7, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES 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, IT WAS REVEALED THAT A GEAR WAS BLOCKED. THIS WAS ATTRIBUTED TO NORMAL WEAR. SERVICE AND MAINTENANCE WERE PERFORMED AND THE DEVICE WAS RETURNED TO THE CUSTOMER ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DEVICE MAKES A STRANGE NOISE AND GETS WARM DURING USE. DEVICE WAS RETURNED FOR SERVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590811 QC F/K-WIRES Ø0.6-3.2 F/532.001 532.010 HWE SYNTHES GMBH 5659

    Patients

    Seq Age Sex Outcome Treatment
    1