BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICAT OUT SHAFT

    MDR report key: 3192615 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04118
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 31, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE COMPLAINED INSTRUMENT HAS BEEN FORWARDED TO THE RESPONSIBLE PRODUCT MANAGER AND WE ARE NOW IN THE RECEIPT OF THE INVESTIGATION RESULTS. THE PRESENT ARTICLES WERE CHECKED FOR CONFORMANCE TO THE SPECIFICATIONS AND FOR FUNCTIONING; NEITHER A PRODUCT NOR A FUNCTION FAULT COULD BE DETECTED. THE INSTRUMENT WORKS WITHOUT ANY PROBLEM AND ABSOLUTELY CORRECT. THE MEASURABLE DIMENSIONS OF THE COMPLAINT INSTRUMENT WERE CHECKED AS FAR AS POSSIBLE AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A T-PAL SURGERY ON (B)(6) 2013, THE T-PAL TRIAL IMPLANT TURNED BEFORE THE KNOB ON THE APPLICATOR WAS OPENED. WHEN THE SURGEON CONTROLLED THE KNOB IT WAS TURNED TO OPEN. THE PLACEMENT OF THE TRIAL IMPLANT WAS CORRECT. THEY USED A DIFFERENT APPLICATOR FOR THE IMPLANT AND THIS WORKED WITHOUT ANY PROBLEMS. WHEN TURNING THE KNOB IT FEELS A LITTLE SLOW ON THE THREADS, AND TAKES MORE POWER TO TIGHTEN. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292474 APPLICAT OUT SHAFT LXH SYNTHES GMBH 3610339

    Patients

    Seq Age Sex Outcome Treatment
    1