BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITER 0.4NM W/AO/ASIF-QC

    MDR report key: 2883777 · Received December 21, 2012

    Report

    Report Number
    8030965-2012-01655
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 23, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS CONDUCTED AT SYNTHES (B)(4). THE INSPECTION FOUND THAT THE COUPLING WAS DAMAGED DURING FORCIBLE USE. NO SIGNS OF RUST COULD BE DETECTED. THE INSTRUMENT SHOWS SEVERAL MARKS OF A FORCEPS AND INADEQUATE USE. THE FILE HISTORY RECORDS SHOW THAT THE DEVICE MET FULLY TO OUR SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE DEVICE WAS NEVER SENT IN FOR SERVICING AND RECALIBRATING WHICH SHOULD BE DONE ANNUALLY, AS PER THE INSTRUCTIONS FOR USE. NO PRODUCT OR MATERIAL FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE DRILL BIT OR TAPPER CANNOT BE ATTACHED TO THE TORQUE LIMITER DUE TO THE RUST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORQUE LIMITER 0.4NM W/AO/ASIF-QC TORQUE LIMITER GEY SYNTHES GMBH SER.-NR. 2058

    Patients

    Seq Age Sex Outcome Treatment
    1