BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE 3M TO CONSOLE

    MDR report key: 4178930 · Received October 16, 2014

    Report

    Report Number
    3009450871-2014-10504
    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
    PK043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE PMA/510(K) NUMBER WAS DOCUMENTED AS EXEMPT IN THE INITIAL REPORT. IT HAS BEEN UPDATED TO K043310. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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 ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. A CONDUCTIVITY ASSESSMENT WAS PERFORMED ON THE DEVICE USING A TEST JIG, WHICH REVEALED THE DEVICE HAD A SHORT CIRCUIT INTERMITTENTLY. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. IT WAS DETERMINED THAT THE CABLE CONDUCTIVITY ISSUES WERE RELATED TO A BROKEN WIRE OR SOLDERING CONTACT WHICH CAN BE CAUSED BY MECHANICAL STRESS, SPECIFICALLY ON THE CONNECTOR, BOTH HAND PIECE OR CONSOLE SIDE. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO MECHANICAL STRESS DURING HANDLING WHICH WAS MISUSE, ABUSE AND/OR USER ERROR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    THIS IS REPORT 2 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
    658753 CABLE 3M TO CONSOLE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 8174856

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSOLE DEVICE| SMALL ELECTRIC DRIVE DEVICE