BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUST PEDICLE SCREWDRIVER - MIS HYBRID

    MDR report key: 7120564 · Received December 15, 2017

    Report

    Report Number
    3005180920-2017-00747
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 15, 2017
    Report Date
    December 15, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 DECEMBER 2017. LOT 1654936: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 MARCH 2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT. VISUAL INSPECTION PERFORMED THE 15TH OF DECEMBER, 2017 BY R&D PRODUCT MANAGER: PICTURE RECEIVED WITH THE COMPLAINT NOTIFICATION WAS ALSO CONSIDERED. BREAKAGE OF THE TIP DURING SCREW INSERTION. BREAKAGE CAN OCCUR IN CASE OF HIGH INSERTION TORQUE, TYPICALLY RELATED TO LARGE DIAMETER SCREWS (>7MM), LONG SCREWS (>60MM) AND/OR HARD BONE (E.G. SACRAL BONE, SCLEROTIC BONE). IN SUCH CASES, BONE TAPPING IS RECOMMENDED IN THE SURGICAL TECHNIQUE AS WELL AS IN PBN (B)(4) . IN THIS CASE, A SCREW Ø6MM WAS INSERTED, WITHOUT TAPPING. NO INFORMATION ABOUT THE BONE QUALITY/HARDNESS. USUALLY THE SURGEON IS ABLE TO PERCEIVES THE HIGH TORQUE DURING THE INSERTION, IN SUCH CASE HE COULD REMOVE THE SCREW AND TAP FURTHER IN DEEP BEFORE REPOSITIONING THE SCREW. THE TIP MATERIAL AND GEOMETRY IS PROVEN TO WITHSTAND UP TO 9NM TORQUE, WHICH IS A SIGNIFICANT FORCE FOR A PEDICLE SCREW INSERTION (NOTE, 9NM IS ALSO THE FINAL TIGHTENING TORQUE FOR THE SETSCREW, THAT NEEDS A T-HANDLE AND A COUNTERTORQUE TO BE APPLIED.) - THE STRENGTH OF THE TIP OF THE SCREWDRIVER IS DRIVEN BY THE DIMENSIONS (HEXALOBE T20) AND THE MATERIAL (AISI X15-TN) WHICH ARE COMPARABLE TO PREDICATE DEVICES. GEOMETRICAL FEATURES ARE DRIVEN BY THE IMPLANT DESIGN AND ARE EQUIVALENT TO SIMILAR PRODUCTS IN THE MARKET. THE MATERIAL IS AMONG THE STRONGEST MATERIALS FOR SUCH APPLICATION IN TERMS OF STRENGTH AND HARDNESS. THE INSTRUMENT SET ALWAYS INCLUDES A SECOND PEDICLE SCREWDRIVER, AND ANOTHER "SIMPLE" SCREWDRIVER (REF (B)(4) OR EQUIVALENT) TO COMPLETE THE SURGERY IN CASE OF BREAKAGE.

    Description of Event or Problem · 1

    THE SCREWDRIVER TIP BROKE UP DURING THE INSERTION OF A SCREW INTO THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903098 MUST PEDICLE SCREWDRIVER - MIS HYBRID SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA 1654936

    Patients

    Seq Age Sex Outcome Treatment
    1 Other