BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY HANDPIECE, MODULAR, FOR TRAUMA RECON SYSTEM

    MDR report key: 3981286 · Received August 5, 2014

    Report

    Report Number
    3009450871-2014-10312
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 25, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE REPORTER¿S NAME WAS NOT PROVIDED. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE BEARING WAS NOT FUNCTIONING AND DEFECTIVE. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE AND SERVICING. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE..

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 3 FOR THE SAME EVENT: IT WAS REPORTED FROM GERMANY THAT THE BATTERY HANDPIECE DEVICE HEATED UP DURING USE. IT WAS REPORTED THAT THE DEVICE WAS IN USE WITH AN ATTACHMENT DEVICE AND LID FOR THE HANDPIECE DEVICE. THE REPORTER WAS UNABLE TO DETERMINE WHICH DEVICE MALFUNCTIONED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457901 BATTERY HANDPIECE, MODULAR, FOR TRAUMA RECON SYSTEM MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES POWER TOOLS 003619

    Patients

    Seq Age Sex Outcome Treatment
    1 LID FOR BATTERY HANDPIECE DEVICE| ATTACHMENT DEVICE