BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI SNAP-ON TRANSCONNECTOR 62MM-90MM FOR 5.5MM/6.0MM RODS

    MDR report key: 3800744 · Received May 8, 2014

    Report

    Report Number
    3003506883-2014-10049
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL DEVICE CODES: MNH, MNI, KWQ, KWP. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS AT TIME OF ACCEPTANCE. NO NONCONFORMING REPORTS WERE NOTED. THE RAW MATERIAL MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED. 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

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: ASSEMBLY WAS IN GOOD CONDITION, NO APPARENT DAMAGE TO MACHINED COMPONENTS. TRANSLATION SCREW DAMAGED. TRANSLATION SCREW WAS REMOVED AND FIRST THREAD IS PEELED BACK ABOUT 1 REVOLUTION. THIS SCREW IS STAKED AT THE BOTTOM SO IT CANNOT BE REMOVED WITHOUT DAMAGING THE SCREW. T-ROD STICKS IN THE CLOSED POSITION AND MAY HAVE BEEN DAMAGED ON END BY TRANSLATION SCREW REMOVAL. THE SNAP-ON TRANSVERSE CONNECTOR IS PREASSEMBLED AND REQUIRES ONLY FINIAL POSITIONING AND TIGHTENING, SO BASED ON THE INVESTIGATION RESULTS FROM THE MANUFACTURING SITE IT WOULD APPEAR THAT USER ERROR WAS THE ROOT CAUSE FOR THIS COMPLAINT. IN ADDITION BASED ON HOW THE PART WAS RETURNED, IT WAS NOT POSSIBLE TO DEFINE WHAT CAUSED THE INITIAL STIFFNESS OF THIS DEVICE. THE TECHNIQUE GUIDE WAS REFERENCED. A REVIEW OF ALL MANUFACTURING RECORDS WAS CONDUCTED AND THERE WERE NO FACTORS THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. THE ARTICLE WAS MANUFACTURED IN THE US MEETING ALL SPECIFICATIONS. A REVIEW OF OUR COMPLAINT HISTORY FOR THIS PART WAS CONDUCTED. NO PRODUCT FAULT COULD BE DETECTED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE TRANSVERSE CONNECTOR WAS TOO STIFF TO ADJUST THE LENGTH, ONCE LOOSENED, THE SET SCREWS REMAINED STUCK. IN ADDITION, THE METAL STRIP CAME OUT FROM THE SET SCREWS TIP AND ANOTHER IMPLANT WAS USED TO COMPLETE THE OPERATION. NO HARM TO THE PATIENT. THIS IS 1 OF 1 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278850 TI SNAP-ON TRANSCONNECTOR 62MM-90MM FOR 5.5MM/6.0MM RODS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES ELMIRA 7606265

    Patients

    Seq Age Sex Outcome Treatment
    1