BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL ELECTRIC DRIVE

    MDR report key: 4178924 · Received October 16, 2014

    Report

    Report Number
    3009450871-2014-10507
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    September 23, 2014
    Report Date
    October 1, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. 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 PMA/510(K) NUMBER WAS DOCUMENTED AS K093361 IN THE INITIAL REPORT. IT HAS BEEN UPDATED TO EXEMPT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, 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 THE REPORTED CONDITION COULD NOT BE DUPLICATED AND CONFIRMED. A FUNCTIONAL ASSESSMENT WAS PERFORMED AND THE DEVICE SHOWED NO ISSUES. POWER MEASUREMENT WAS PERFORMED AND THE DEVICE PASSED SUCCESSFULLY. THE PRODUCTION DOCUMENTATION OF THE DEVICE WAS REVIEWED AND THERE WERE NO ISSUES FOUND. THEREFORE, AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED FROM FRANCE THAT DURING AN UNSPECIFIED VETERINARY SURGICAL PROCEDURE ON A CANINE, IT WAS OBSERVED THAT SMALL ELECTRIC DRIVE DEVICE STOPPED WORKING WHILE IN USE WITH A CONSOLE DEVICE AND A CABLE DEVICE. ACCORDING TO THE REPORT, THE DEVICE STOPPED IN THE FORWARD POSITION. IT WAS FURTHER REPORTED THAT THE DEVICE WORKED FOR ABOUT ONE MINUTE IN THE REVERSE POSITION, AND THEN COMPLETELY STOPPED. THERE WAS A DELAY OF TWENTY MINUTES TO THE PLANNED SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS WAS A VETERINARY PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    658735 SMALL ELECTRIC DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CABLE DEVICE| CONSOLE DEVICE