BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITER 1.5NM F/COMPACT AIR DRIVE

    MDR report key: 3962189 · Received July 28, 2014

    Report

    Report Number
    9612488-2014-10306
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: MATERIAL RECEIVED NOT ORIGINAL PACKED WITH SIGNS OF USAGE WITHOUT DAMAGES. THE INVESTIGATIONS OF THE WORK ORDER SHOWS THAT EVERY TORQUE LIMITER WAS 100% TESTED IN THE FUNCTION AND TORQUE. TORQUE LIMITER WAS TESTED ACCORDING TO THE NEW TEST INSTRUCTION AND THE RESULTS PASSED. NO PRODUCT FAULT COULD BE FOUND. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 THAT THE DEVICE IS NOT WORKING PROPERLY. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO DELAY IN THE PROCEDURE AND NO PATIENT HARM. THIS DEVICE INVOLVES ONE DEVICE THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439841 TORQUE LIMITER 1.5NM F/COMPACT AIR DRIVE MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY SYNTHES BETTLACH 2092962

    Patients

    Seq Age Sex Outcome Treatment
    1