BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH® XMAX

    MDR report key: 4151773 · Received October 8, 2014

    Report

    Report Number
    1045834-2014-13391
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 20, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK131053
    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 SYNTHES OUS 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 FOUND DAMAGED BEARINGS DUE TO NORMAL WEAR .

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE QD FAMILY ATTACHMENTS WERE NOT ATTACHED. THE DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE, THE TECHNICIAN FOUND THE HOSE DAMAGED, OIL LEAK, THE SCREWS FROM THE WZ COUPLING WERE LOOSE AND THE ROTATIONAL SPEED HAD TOO MANY FLUCTUATIONS. THE BEARINGS, LAMELLAE, GASKETS, AND COUPLINGS WERE REPLACED AND A NEW HOSE WAS ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632963 ANSPACH® XMAX DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1