BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 -

    MDR report key: 8099787 · Received November 23, 2018

    Report

    Report Number
    3005180920-2018-00942
    Event Type
    Malfunction
    Date Received
    November 23, 2018
    Date of Event
    October 25, 2018
    Report Date
    January 3, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630040716086
    PMA / PMN Number
    K171758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED DECEMBER THE 18TH, 2018. THE PROVIDED IMAGES HAVE BEEN CONSIDERED FOR THE INSPECTION. THE FOLLOWING SURGICAL STEPS HAVE BEEN DONE BY THE SURGEON: ROD REDUCTION AND SETSCREW TEMPORARY LOCKING USING 1-STEP REDUCER, FINAL TIGHTENING BY MEANS OF COUNTERTORQUE AND TORQUE LIMITER. AFTER THESE STEPS, IT WAS NOTICED A STRIPPED THREAD OF THE SETSCREW. LOOKING AT THE IMAGES, THE DAMAGED THREAD SEEMS THE LOWEST OR ONE OF THE LOWERS. A POTENTIAL ROOT CAUSE COULD BE THAT IT WAS PARTIALLY DAMAGED DURING THE MANEUVRES PRIOR TO SCREW-TULIP CORRECT ENGAGEMENT, AND THEN FINALLY STRIPPED WHEN THE 9NM TORQUE WAS APLLIED WITH THE TORQUE LIMITER. THE 1-STEP REDUCER RECEIVED (REF 03.51.10.0181) DOESN'T HAVE A COMPROMISED FUNCTIONALITY AND HAS BEEN SUCCESSFULLY USED FOR ROD REDUCTION AND SETSCREW TEMPORARY LOCKING ON A SAWBONES.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 NOVEMBER 2018: LOT 1820484: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 JUNE 2018. EXPIRATION DATE: 2023-05-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PEDICLE SCREW ONE-STEP REDUCER ENHANCED (SURGICAL INSTRUMENT): LOT 1850416: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 JUNE 2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENT ON THE SAME LOT HAS BEEN REGISTERED. PRELIMINARY INVESTIGATION PERFORMED BY R&D PRODUCT MANAGER ON NOVEMBER 21, 2018: DEFORMATION AND DELAMINATION OF THE THREAD START OF THE SET SCREW DURING "INSETION" ON THE PEDICLE SCREW HEAD TULIP. SIMILAR FAILURE COULD BE THEORETICALLY RELATED TO CROSS-THREADING AND/OR WRONG "ALIGNEMENT" BETWEEN SET SCREW AND TULIP. HOWEVER, BASED ON THE EVENT DESCRIPTION, THE ONE-STEP REDUCER 03.51.10.0181 WAS USED; THEREFORE, CROSS-TREADING IS UNLIKELY. ALSO THE PICTURES SHOW THAT AT THE END OF THE TIGHTENING THE SET SCREW IS WELL PLACED, NO CROSS-THREADING OR "MISALIGNEMENT". ANOTHER CAUSE OF THIS ISSUE COULD BE THE PRESENCE OF BURRS OR SHARP EDGES AT THE BEGINNING OF THE THREAD - PRODUCTION DEFECT. IN THIS CASE, THE SET SCREW NEEDS TO BE REMOVED AND REPLACED WITH A NEW ONE, AVAILABLE AS SPARE PART IN THE IMPLANT KIT.

    Description of Event or Problem · 1

    DURING A L5-S1 FUSION SURGEON USED THE ONE STEP REDUCER TO REDUCE THE ROD INTO THE SCREW HEAD. THIS WENT WELL; SET SCREW WENT IN WITHOUT FRICTION. FOR ONE OF THE SET SCREW REDUCTION COUNTER-TORQUE AND TORQUE LIMITER WERE USED TO FINAL TIGHTEN THE CONSTRUCTION UNDER COMPRESSION. AFTER THIS MANEUVER, THE SURGEON DID A LAST CHECK INSIDE AND HE SAW A STRIPPED THREAD FROM THE SET SCREW THAT STUCK OUTSIDE THE TULIP. THE SET SCREW WAS REMOVED "AN" SWAPPED WITH A NEW ONE WITHOUT CRITICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938747 PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 1820484 07630040716086

    Patients

    Seq Age Sex Outcome Treatment
    1 Other