BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3111882 · Received May 7, 2013

    Report

    Report Number
    1045834-2013-02091
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 8, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOTOR DEVICE WAS REC'D FOR EVAL. THE MOTOR DEVICE WAS EVALUATED AND THE REPORTED CONDITION WAS NOT CONFIRMED. HOWEVER, THE DEVICE DID NOT MEET MFG SPECIFICATIONS. THERE WAS EVIDENCE OF IMMERSION DURING CLEANING. IF ADD'L INFO IS REC'D, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT REC'D FROM THE USA STATING THAT THE MOTOR DEVICE HAD "AN ABRASION TWENTY-FOUR INCHES FROM THE MUFFLER END." THE ALLEGED MALFUNCTION WAS DISCOVERED DURING SET-UP FOR A CRANIOTOMY PROCEDURE BEFORE THE PT ENTERED THE ROOM. THERE WAS A 1-2 MIN DELAY IN SURGERY. AN IDENTICAL MOTOR DEVICE WAS AVAILABLE. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198038 XMAX MOTOR ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1