BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH® XMAX

    MDR report key: 4182831 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14559
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 12, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK131053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. THE DEVICE RETURNED FOR SERVICE. DURING THE EVALUATION THE TECHNICIAN FOUND THE DEVICE WAS NOT FUNCTIONING PROPERLY. DURING SERVICE, TECHNICIAN FOUND LOW POWER AND BEARING WORN FROM USE. DURING SERVICE, THE TECHNICIAN REPAIRED THE DEVICE. SERVICE RECORDS INDICATED THAT THE DEVICE FAILED SOUND, AND RPM TESTINGS. THE DEVICE WAS SUBSEQUENTLY REPAIRED. MANUFACTURING DATE FOR THIS DEVICE IS UNAVAILABLE.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR SERVICE.(B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661965 ANSPACH® XMAX DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL DEPUY SYNTHES POWER TOOLS 5035793302

    Patients

    Seq Age Sex Outcome Treatment
    1