BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH® XMAX

    MDR report key: 4183293 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-12976
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    February 4, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK131053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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, INVESTIGATION REVEALED THE DEVICE COMES APART, THE COUPLING DEFECTIVE AND PIN IS TORN OUT. THE DEVICE WAS REPAIRED BY REPLACING VARIOUS COMPONENTS AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DEVICE LOCKING SYSTEM DEFECTIVE, BLOCKING THE HAND PIECE CAUSING IT TO OVERHEAT AND THE ANCHOR PIN ADAPTER IS MISSING. THIS IS REPORT 1 OF 1 FOR #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660144 ANSPACH® XMAX DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1