BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY REAMER/DRILL

    MDR report key: 4131614 · Received October 1, 2014

    Report

    Report Number
    8030965-2014-00464
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    April 8, 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

    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 TECHNICIAN, FUNCTIONAL TESTING REVEALED THE COUPLING SIDE WAS DEFECTIVE DUE TO NORMAL WEAR. THE COUPLING SPRINGS WERE REPLACED AND DEVICE EXTENSIVELY TESTED BEFORE RETURNING TO CUSTOMER ON (B)(4) 2013. (B)(6). PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE MOTOR OVERHEATED AND THE DEVICE WAS NO LONGER OPERATIONAL. THIS IS REPORT 1 OF 1 FOR #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612062 BATTERY REAMER/DRILL MOQ SYNTHES GMBH 4311

    Patients

    Seq Age Sex Outcome Treatment
    1