BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3872881 · Received June 13, 2014

    Report

    Report Number
    8030965-2014-10302
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 30, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT REPORTED TO HAVE OCCURED DURING SURGERY. IT WAS NOT REPORTED IF ANY PATIENT OR USER INJURIES OCCURRED. THERE WAS NO INFORMATION REPORTED REGARDING SPARE DEVICE AVAILABILITY. IT WAS NOT REPORTED IF THERE WAS ANY MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. DEVICE EVALUATION:THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE BOTTOM TRIGGER WAS DAMAGED. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO DEVICE BEING WORN DUE TO NORMAL USE AND SERVICING OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE, THE BOTTOM KNOB OF THE SMALL BATTERY DRIVE WAS NOT RELEASING. IT WAS UNKNOWN TO THE REPORTER IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS UNKNOWN IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THE EXACT DATE OF THE 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
    349986 SMALL BATTERY DRIVE INSTR.SURGICAL. ORTHOPEDIC.AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES OBERDORF 4227

    Patients

    Seq Age Sex Outcome Treatment
    1