BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLICATOR INNER SHAFT

    MDR report key: 2980920 · Received February 27, 2013

    Report

    Report Number
    8030965-2013-00649
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A VISUAL CHECK AND A HANDLING TEST WERE PERFORMED. THE ARTICLE SHOWS SIGNS OF WEAR DUE TO THE NUMBER OF CYCLES OF USE. BY USING THE OTHER BROKEN APPLICATOR INNER SHAFT BOTH APPLICATOR KNOBS ARE COMING OFF FROM THE APPLICATORS OUTER SHAFTS. THE OTHER COMBINATIONS BETWEEN THIS APPLICATOR INNER SHAFT, APPLICATORS OUTER SHAFT AND APPLICATOR KNOBS WERE TESTED AND NO MALFUNCTION WAS NOTICED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING THE INSERTION OF A T-PAL CAGE WITH THE T-PAL APPLICATOR THE CAGE COULD NOT BE FIXED PROPERLY ON THE APPLICATOR. EVEN THOUGH THE APPLICATOR KNOB WAS TURNED CLOCKWISE TO SECURE THE IMPLANT AND THE SECURITY RING MOVED UPWARDS, THE GREEN COLOR BAND WAS VISIBLE AND THE KNOB CAME LOOSE FROM THE APPLICATOR SHAFT. CONSEQUENTLY IT WAS NOT POSSIBLE TO DO A GUIDED INSERTION AS THE T-PAL CAGE WAS PIVOTING DURING INSERTION. THIS LED TO AN EXTENSION OF THE SURGICAL TIME OF 1 HOUR. THIS REPORT IS #3 OF 4 FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS 3 OF 4 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83662 APPLICATOR INNER SHAFT INNER SHAFT LXH SYNTHES GMBH 3416683

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention