BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM LONG HEXAGONAL SCREWDRIVER WITH T-HANDLE

    MDR report key: 3831661 · Received May 26, 2014

    Report

    Report Number
    3003875359-2014-10144
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. 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. : NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT: THE 3.5 MM LONG HEXAGONAL SCREWDRIVER WITH T-HANDLE (PART# 388.364) IS USED FOR PEDICLE SCREW INSERTION OF PREASSEMBLED SCREWS WITH THE CLICK¿X SYSTEM. THE TECHNIQUE GUIDE WAS REVIEWED FOR INSTRUCTIONS FOR USE ((B)(4)). TWO 3.5 MM LONG HEXAGONAL SCREWDRIVERS WITH T-HANDLE (PART# 388.364, LOT#S 3579721 AND 1240905 (SYNTHES LOT 494223)) WERE RETURNED WITH THE COMPLAINT OF THE DRIVER TIPS HAVING BROKEN OFF DURING SURGERY. THIS COMPLAINT CONDITION IS CONFIRMED, AS THE DISTAL MOST SEGMENT OF THE DRIVER TIPS (WITH 2MM RADIUS) ARE MISSING FROM THESE DEVICES. IT IS NOT KNOWN WHAT CAUSED THE TIPS TO BREAK OFF INTO THE SCREWS DURING THE SURGICAL PROCEDURE, HOWEVER OFF-AXIS ROTATION WHILE NOT FULLY SEATED IN THE PEDICLE SCREW WOULD LEAD TO THIS COMPLAINT CONDITION, GIVEN BOTH THE GEOMETRY OF THE TIP AND THE TECHNIQUE GUIDE NOTATION TO ENSURE THAT THE SCREW IS NOT ANGULATED PRIOR TO INSERTION OF THE DRIVER. THE DESIGN OF THIS DEVICE CANNOT BE RULED OUT AS CONTRIBUTING TO THIS 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 A PATIENT HAD REVISION SURGERY DUE TO A ROD THAT BROKE BETWEEN L5-S1 ON BOTH SIDES DUE TO PSEUDOARTHROSIS. THE ROD BREAKAGE WAS DISCOVERED DURING A VISIT TO THE SURGEON THROUGH MAGNETIC RESONANCE IMAGING (MRI). DURING THE SURGERY, THE CAPS WERE REMOVED AND THE BROKEN ROD WAS REMOVED, ONE LOOSE SCREW WAS REPLACED. THE RODS WERE REPLACED WITH TITANIUM ALUMINUM NIOBIUM (TAN) RODS AND NEW CAPS WERE PLACED. A FINAL TIGHTENING TORQUE WRENCH WAS USED TO FINAL TIGHTEN ALL THE CAPS. A CAGE WAS PLACED THROUGH THE L5-S1 DISC SPACE. A TRANS-CONNECTOR WAS PLACED BETWEEN L5-S1 SCREWS. IT WAS ALSO REPORTED THAT SEVERAL INSTRUMENTS WERE DAMAGED DURING THE BROKEN ROD REVISION SURGERY AND SEVERAL INSTRUMENT TIPS BROKE OFF. THE SCREWS AND TIPS WERE REMOVED FROM THE CAPS OF THE DEVICES, SOME TIPS LANDED IN THE CAPS, AND PATIENT WITH NO HARM TO THE PATIENT. NO PATIENT HARM WAS REPORTED DURING THE REVISION SURGERY. A TIME DELAY OF 15 MINUTES WAS REPORTED. IT WAS REPORTED THE INSTRUMENTS MAY HAVE BEEN DAMAGED DURING THE PROCESS DUE TO THE DIFFICULT ANGLE OF THE L5-S1 SLOPE. THIS IS REPORT 7 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309902 3.5MM LONG HEXAGONAL SCREWDRIVER WITH T-HANDLE SCREWDRIVERS HXX SYNTHES HAGENDORF 3579721

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR