BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3953697 · Received July 23, 2014

    Report

    Report Number
    8030965-2014-10397
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE MET ALL MANUFACTURERS' SPECIFICATIONS. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PIN REMOVAL PROCEDURE ON A CANINE, IT WAS OBSERVED THAT THE PIN DEVICE GOT STUCK IN THE QUICK COUPLING DEVICE. THE REPORTER STATED THAT AFTER THE PIN WAS REMOVED FROM THE CANINE PATIENT, THE PIN WAS VERY DIFFICULT TO REMOVE FROM THE DEVICE. THE REPORTER NOTED THAT THE PIN WAS VERY SMOOTH BEFORE REMOVAL, BUT NOW HAS A NOTCH IN IT WHERE THE DEVICE CLAMPED DOWN. IT WAS CLARIFIED THAT THE SURGEON WAS BEING CAREFUL WHEN REMOVING THE PIN FROM THE PATIENT AND NOT APPLYING HEAVY TORQUE. AS A RESULT, THERE WAS A 15-20 MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS UNKNOWN IF A SPARE DEVICE AS AVAILABLE FOR USE. HOWEVER, IT WAS CLARIFIED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS DEVICE WAS FOR VETERINARY USE ONLY AND WAS NOT BEEN USED ON HUMAN PATIENTS. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE REPORTER STATED THAT THIS WAS THE FIRST USE OF THE DEVICE AFTER BEING RECENTLY SERVICED FOR THE SAME ISSUE. 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
    432403 SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF 13878

    Patients

    Seq Age Sex Outcome Treatment
    1