BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2014-00444

    MDR report key: 3611924 · Received February 7, 2014

    Report

    Report Number
    2520274-2014-00444
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Report Date
    January 13, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.(B)(4)

    Additional Manufacturer Narrative · 1

    SERVICE HISTORY WAS REVIEWED FOR THIS DEVICE AND DETERMINED THAT THERE WERE NO PRIOR SERVICE REPORTS. SERVICE RECORD EVALUATION: A PRE-REPAIR DIAGNOSTIC ASSESSMENT REVEALED THAT THE TORQUE WAS OF TOLERANCE DUE TO NORMAL WEAR ON THE DEVICE. THE DEVICE WAS REPAIRED. AFTER SERVICE, THE EXECUTION OF THE FINAL INSPECTION HAS BEEN PERFORMED THROUGH REGULAR FUNCTIONALITY CHECKS OF THE PRODUCT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS IS REPORT IS ON AN UNKNOWN TORQUE LIMITER, PART AND LOT NUMBERS ARE UNKNOWN. WITHOUT A PART NUMBER THE 510K NUMBER CANNOT BE PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    TECHNICAL SERVICE IN EU SYNTHES SERVICE AND REPAIR, (B)(6), REPORTED: TORQUE LIMITER 1.5NM F/COMPACT AIR DRIVE: TORQUE OUT OF TOLERANCE. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79995 FZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1