BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4151254 · Received October 8, 2014

    Report

    Report Number
    8030965-2014-00775
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    July 31, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO (B)(4) AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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 IS WORN OUT. THIS WAS ATTRIBUTED TO NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON 08/21/2013. (B)(6). PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DEVICE WAS OVER HEATING. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632617 QC F/K-WIRES Ø0.6-3.2 F/532.001 532.010 HWE SYNTHES GMBH 7211

    Patients

    Seq Age Sex Outcome Treatment
    1