BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC+F/PINS Ø1.5-4

    MDR report key: 6047760 · Received October 21, 2016

    Report

    Report Number
    8030965-2016-15278
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 7, 2016
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(4). (B)(6). 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

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND FOUND THAT THE COUPLING TOOL SIDE WAS WORN OUT. IT WAS ALSO NOTED THAT THE COUPLING TOOL WAS SLIGHTLY DIRTY AND THEREFORE, THE SPIKE WIRES WERE NOT CLAMPING PROPERLY. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO PREMATURE WEAR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE QUICK COUPLING DEVICE HANDLE WAS STICKING AND WAS NOT GRIPPING THE WIRE. IT WAS REPORTED THAT THERE WAS A FOUR MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT AND AN UNSPECIFIED SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO PATIENT OR USER INJURIES REPORTED. IT WAS REPORTED THERE WAS NO 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
    697702 QC+F/PINS Ø1.5-4 MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY SYNTHES OBERDORF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 WIRE DEVICE