BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH® XMAX

    MDR report key: 4142456 · Received October 5, 2014

    Report

    Report Number
    1045834-2014-13438
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Report Date
    July 18, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK131053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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, TECHNICIAN FOUND BEARINGS WORN DUE TO NORMAL WEAR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE AIR WAS LEAKING INSIDE THE HOSE AND THE INNER HOSE WAS DISCONNECTED. DURING SERVICE, THE TECHNICIAN FOUND OUT THAT THE DEVICE DID NOT HAVE MUCH POWER, THE LATCH WAS FAULTY AND THE BEARING WAS WORN FROM USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621973 ANSPACH® XMAX DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1