BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROMAX-PLUS LP MOTOR ASSY

    MDR report key: 3963902 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-14631
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    March 9, 2011
    Report Date
    July 27, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT REC'D FROM (B)(6) STATING THAT THE DEVICE DID NOT FUNCTION AND THE DEVICE MOTOR ROTATED WHEN LOCK WAS ON. THE DEVICE WAS NOT USED IN SURGERY. IT IS UNKNOWN IF INJURY, SURGICAL DELAY, OR MEDICAL INTERVENTION OCCURRED. THERE IS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652898 MICROMAX-PLUS LP MOTOR ASSY ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1