BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI COLLAR WITH GROOVES

    MDR report key: 6737157 · Received July 24, 2017

    Report

    Report Number
    2530088-2017-10231
    Event Type
    Malfunction
    Date Received
    July 24, 2017
    Date of Event
    June 26, 2017
    Report Date
    June 26, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNI
    UDI-DI
    10705034788593
    PMA / PMN Number
    K141897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ADDITIONAL PRODUCT CODES: MNH, KWP, KWQ, NKB. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW FOR PART #498.011, SYNTHES LOT #9932900. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. RELEASE TO WAREHOUSE DATE: 28-OCT-2015, MANUFACTURED BY SYNTHES (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. THE TI COLLAR WITH GROOVES (PART # 498.011, LOT NUMBER 9932900), WAS RETURNED WITH A PORTION OF THE COLLAR BROKEN OFF. AN APPROXIMATELY 2.31 MM X 1.8 MM X 2.79 MM (L X W X H) PIECE OF THE COLLAR IS MISSING, THE FRAGMENT WAS NOT RETURNED. THIS COMPLAINT IS CONFIRMED. A VISUAL INSPECTION, DHR REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DEVICES ARE ALREADY BROKEN. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT THIS COMPLAINT CONDITION WAS DUE TO EXCESSIVE (CYCLICAL) LOADING APPLIED TO THE COLLAR CAUSING MATERIAL FATIGUE AND BREAKAGE. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE DEVICES MALFUNCTIONED DURING A T4-L2 SCOLIOSIS PROCEDURE ON (B)(6) 2017. DURING THE PROCEDURE, A HOOK POSITIONER HAD A CHUNK COME OUT OF THE PHENOLIC HANDLE DURING MALLETING. THE CHUNK WAS RECOVERED EASILY. LATER, A SOCKET WRENCH WITH STRAIGHT HANDLE SPLIT INTO TWO PIECES DURING MALLETING. ALL PIECES WERE RECOVERED. FINALLY, UPON FINAL TIGHTENING, THE SURGEON NOTICED THAT A TITANIUM (TI) COLLAR WITH GROOVES AT T8 LEFT WAS BROKEN TOWARD THE END OF THE PROCEDURE. THE BROKEN DEVICE WAS EASILY AND QUICKLY REMOVED AND ANOTHER COLLAR WAS IMPLANTED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. CONCOMITANT DEVICES REPORTED: TITANIUM NUT 11MM WIDTH ACROSS FLATS (PART 498.003, LOT NUMBER UNKNOWN, QUANTITY 1); 5.0MM TITANIUM SIDE-OPENING SCREW 35MM (PART 498.535, LOT NUMBER UNKNOWN, QUANTITY 1); MALLET (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TITANIUM COLLAR WITH GROOVES. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518476 TI COLLAR WITH GROOVES ORTHOSIS, PEDICLE SPINAL FIXATION MNI SYNTHES BRANDYWINE 498.011 9932900 10705034788593

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR