BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-PAL SMALL TRIAL IMPLANT SIZ 9 NON DETA

    MDR report key: 2944944 · Received February 6, 2013

    Report

    Report Number
    8030965-2013-00330
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MAX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT HAS RETURNED, INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DISTAL TIP OF THE INSTRUMENT IS INDEED BROKEN OFF. WE DO SUPPOSE THOUGH THAT THE DAMAGE OF THE T-PAL SMALL TRIAL IMPLANT INNER SHAFT MAY HAVE BEEN CAUSED DUE TO HIGH MECHANICAL FORCE WHICH WAS APPLIED DURING USE, HAMMERING. NOTE THAT THIS IS A RATHER DELICATE INSTRUMENT. WE HAVE NOT HAD A SINGLE COMPLAINT OF THIS PARTICULAR ITEM SO FAR. NEVERTHELESS, AS WE HAVE HAD SIMILAR COMPLAINTS OF SUCH NATURE WITH OTHER INSTRUMENTS, OUR PDC HAS DECIDED TO REVISIT THIS PARTICULAR DESIGN IN ORDER TO ELIMINATE SUCH PROBLEMS IN THE FUTURE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DEVIATION TO THE SPECIFICATION WAS FOUND. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: SURGEON INSERTED T-PAL TRIAL IMPLANT WITH IMPACTING ON THE APPLICATOR. X-RAY WAS TAKEN FOR PLACEMENT AND THE SURGEON DETERMINED FURTHER DISC PREPARATION WAS NEEDED. TRIAL IMPLANT WAS REMOVED BY HAMMERING. SURGEON THEN RE INSERTED THE TRIAL AND NOTICED THE TIP OF THE TRIAL WAS NOT RIDGED BUT FLEXIBLE. THE TIP OF THE TRIAL SHEARED INTO A VEIN THAT HE HAD BEEN TRYING TO AVOID DURING THE OPERATION. THE TRIAL WAS REMOVED AND THE BLEEDING CONTROLLED WITH BIPOLAR FORCEPS. ON CLOSER EXAMINATION OF THE TRIAL, IT WAS NOTED THAT THE ROUND BALL ON THE END OF THE TRIAL HAD SNAPPED OFF AND BROKEN IN THE T-PAL APPLICATOR. THE ROUND END WAS REMOVED FROM THE APPLICATOR AND THE BROKEN TRIAL SET ASIDE. ANOTHER WAS SELECTED AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50897 T-PAL SMALL TRIAL IMPLANT SIZ 9 NON DETA T-PAL SMALL TRIAL IMPLANT MAX SYNTHES GMBH 7542755

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention