BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO/ASIF-QC F/532.001+532.010

    MDR report key: 4143575 · Received October 6, 2014

    Report

    Report Number
    8030965-2014-00994
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    June 3, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. (B)(6). DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE COUPLING TOOL SIDE DID NOT FUNCTION PROPERLY. THIS WAS ATTRIBUTED TO NORMAL WEAR. A BEARING AND AN O-RING WERE REPLACED. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON 07/04/2013. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IF THE DRILL WAS PERFORMED, THE TIP WAS LOOSENED AND DECOMPOSED. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623380 AO/ASIF-QC F/532.001+532.010 HWE SYNTHES GMBH MA2062

    Patients

    Seq Age Sex Outcome Treatment
    1