BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH® XMAX

    MDR report key: 4151662 · Received October 8, 2014

    Report

    Report Number
    1045834-2014-13296
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    January 3, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK131053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE BLADES WERE BROKEN AND HOSE WAS DEFECTIVE. THIS WAS ATTRIBUTED TO NORMAL WEAR. THE HOSE, BLADES, AND BEARINGS WERE REPLACED. SERVICE WAS PERFORMED AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2013.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR SERVICE WITH THE COMPLAINT OF "IT DOESN'T WORK AT ALL, HOSE DAMAGE, AIR LEAKING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633190 ANSPACH® XMAX DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1