BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 6290063 · Received January 31, 2017

    Report

    Report Number
    8030965-2017-10531
    Event Type
    Malfunction
    Date Received
    January 31, 2017
    Date of Event
    January 12, 2017
    Report Date
    January 12, 2017
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE RETURNED TO MANUFACTURER WAS DOCUMENTED AS JAN 24, 2017 ON THE INITIAL REPORT. IT HAS BEEN UPDATED AS MAR 6, 2017. DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE MOTOR SEIZED, JAMMED AND MOVED HEAVY. IT WAS ALSO NOTED THAT THE DEVICE WAS DIRTY. IT WAS ALSO OBSERVED THAT THE DEVICE FAILED THE FOLLOWING PRE-TESTS: CHECKS FOR THE TRIGGERS AND ELECTRONIC CONTROL UNIT (ECU) FUNCTION AND COMPATIBILITY BETWEEN (SMALL BATTERY DRIVE) COLIBRI/SBD (SMALL BATTERY DRIVE) AND COLIBRI II/SBD II. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL WEAR FROM USE AND SERVICING OVER TIME. 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

    GTIN IS UNAVAILABLE AS THE PRODUCT MADE PRIOR TO COMPLIANCE DATE; (11)011207(21)01197. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. 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 UNSPECIFIED VETERINARY SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE SMALL BATTERY DRIVE DEVICE WAS RUNNING SLOW AND A LITTLE ROUGH AND MADE A LOUD SCREECHING NOISE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO THE PLANNED SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE REPORTED DEVICE. 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
    72021 SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF 01197

    Patients

    Seq Age Sex Outcome Treatment
    1