BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY REAMER/DRILL

    MDR report key: 4143705 · Received October 6, 2014

    Report

    Report Number
    8030965-2014-01126
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    June 13, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE DEVICE DID NOT FUNCTION PROPERLY. ALSO THE TECHNICIAN FOUND THE BUTTON HAD SNAPPED OFF. THIS WAS CONTRIBUTED TO NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE, TECHNICIAN FOUND THAT THE BACKBUTTON HAD SNAPPED OFF. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624118 BATTERY REAMER/DRILL MOQ SYNTHES GMBH 3313

    Patients

    Seq Age Sex Outcome Treatment
    1