BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3925172 · Received July 10, 2014

    Report

    Report Number
    8030965-2014-10387
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Report Date
    June 12, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    SERVICE HISTORY REVIEW OF THE DEVICE HAS BEEN PERFORMED. THE REVIEW INDICATES THAT THE DEVICE HAS NOT BEEN SERVICED DURING THE PAST 6 MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINT ISSUE. THE SERVICE TECHNICIAN NOTED THE FOLLOWING ACTION TAKEN: REPAIR. THE DEVICE HAS BEEN SERVICED AND FUNCTIONAL TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH THE SERVICE & REPAIR PROCEDURE (B)(4). DURING THE PRE-REPAIR DIAGNOSTIC ASSESSMENT THE SERVICE TECHNICIAN IDENTIFIED THE FOLLOWING FAILURE: MOTOR SEIZED, ROUGH RUNNING, DEFECT. THE SERVICE TECHNICIAN IDENTIFIED THE PROBABLE ROOT CAUSE: NORMAL WEAR FROM USE AND SERVICING. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE SMALL BATTERY DRIVE WAS NOT FUNCTIONING. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404485 SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE SYNTHES OBERDORF

    Patients

    Seq Age Sex Outcome Treatment
    1