BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH WITH STRAIGHT HANDLE-11MM WIDTH ACROSS FLATS

    MDR report key: 3831670 · Received May 26, 2014

    Report

    Report Number
    3003787298-2014-10023
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXC
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DHR WAS REVIEWED AND REPAIR WAS FOUND ON P/N 388.15, LOT #5808498, WORK ORDER # (B)(4). ONE SOCKET WRENCH WITH STRAIGHT HANDLE WAS RETURNED FOR LOOSE COMPONENT. THE DEVICE WAS REPAIRED, INSPECTED AND RETURNED TO SERVICE ON (B)(4) 2013. THIS REPAIR IS NOT RELEVANT TO THE COMPLAINT CONDITION OF BENT AND STRIPPED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: 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

    ADDITIONAL NARRATIVE: A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE UNIVERSAL SPINAL SYSTEM (USS) IS USED TO CORRECT SCOLIOSIS BY SEGMENTAL CORRECTION OR GLOBAL DEROTATION WITH A LOW-PROFILE SYSTEM. THE SOCKET WRENCH WITH STRAIGHT HANDLE 11MM BELONGS TO THIS SYSTEM, AS WELL AS THE USS VARIABLE AXIS SCREW SYSTEM AND IS USED TO APPLY, SEAT AND TIGHTEN THE NUTS AND COLLARS. THE TECHNIQUE GUIDES WERE REVIEWED (J4437-B AND J3911-G). THE SOCKET WRENCH WITH STRAIGHT HANDLE, 11MM (PART# 388.15, LOT# 5808498) WAS RETURNED WITH THE COMPLAINT OF BEING STRIPPED. THE INSTRUMENT SHOWS MINIMAL SIGNS OF WEAR, AND THE INTERNAL HEXAGONAL DIMENSIONS WERE WITHIN TOLERANCE AND DID NOT SHOW SIGNS OF ROUNDING AT THE CORNERS. THE DRAWINGS, MATERIALS AND ASSOCIATED WITH THIS DEVICE WERE REVIEWED (388_15 REV F, 388_15_1 REV C, 388_15_2 REV B) AND WERE FOUND TO BE ADEQUATE FOR THE DEVICE¿S INTENDED USE. THIS SOCKET WRENCH WAS MANUFACTURED JUNE 12, 2008 TO THE CURRENT DRAWING REVISIONS. IN CONCLUSION, THE DESIGN OF THIS DEVICE WAS FOUND TO BE ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. AS THE PART WAS RETURNED IN GOOD CONDITION AND MEASUREMENTS WERE WITHIN TOLERANCE. 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. IT WAS REPORTED THAT THE SOCKET WRENCH WAS STRIPPED. THIS IS REPORT 1 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309935 SOCKET WRENCH WITH STRAIGHT HANDLE-11MM WIDTH ACROSS FLATS WRENCH HXC SYNTHES BRANDYWINE 5808498

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR