BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER SHAFT T25 STRAIG

    MDR report key: 2831454 · Received October 11, 2012

    Report

    Report Number
    8030965-2012-01029
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 13, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL INFORMATION PROVIDED BY SYNTHES (B)(4). THE TIP OF THE DRIVER GOT TWISTED DURING SCREW REMOVAL. NO MANUFACTURING RELATED ISSUES WERE FOUND. THE CAUSE OF FAILURES ARE NOT DUE TO ANY MANUFACTURING DEFECTS. WE HAVE TO ASSUME THAT EXCEEDING APPLIED MECHANICAL FORCE LED TO THE DEFORMATION. NOTE: BOTH SCREWDRIVER SHAFTS ARE DESIGNED FOR SCREW INSERTION, NOT REMOVAL.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    STERILIZATION VALIDATION DOCUMENTATION, DECISION FINDING PROTOCOLS, DFPS, WAS REVIEWED AND DEMONSTRATED THAT EACH OF THE PART NUMBERS INCLUDED WITHIN THIS COMPLAINT HAD BEEN EVALUATED FOR STERILIZATION. THE STERILIZATION PARAMETERS ARE CONSISTENT WITH SYNTHES CURRENT IFUS, AND THE SUPPORTING VALIDATIONS DEMONSTRATE THAT A STERILITY ASSURANCE LEVEL, SAL, OF 10-6 IS ACHIEVABLE WHEN THE IFUS ARE EMPLOYED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. CORRECTED FROM YES TO NO. DEVICE IS AN INSTRUMENT AND IS NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: PT HAD SPINE PROCEDURE ON (B)(6) 2012 AND WAS IMPLANTED WITH ARCOFIX AND SYNEX IMPLANTS. FIFTY (50) DAYS LATER PT DEVELOPED AN INFECTION. PT RETURNED TO OPERATING ROOM TO HAVE HARDWARE REMOVED ON AN UNK DATE. DURING REMOVAL OF THE SCREWS THE T25 SCREW DRIVER SHAFT BROKE AND THE HOLDER FOR MIS RODS BROKE. THE REMOVAL WAS COMPLETED, PATIENT IS RECEIVING ANTIBIOTICS. THIS IS 1 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCRDRIVER SHAFT T25 STRAIG SCRDRIVER SHAFT T25 HXX SYNTHES GMBH 1896587

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR SYNEX| SCREW| HOLDER| SCREW DRIVER SHAFT| ARCOFIX