BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL REDUCTION PEDICLE SCREWDRIVER 2.0 CANNULATED

    MDR report key: 8089809 · Received November 20, 2018

    Report

    Report Number
    3005180920-2018-00925
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    October 22, 2018
    Report Date
    November 20, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630971230767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 NOVEMBER 2018: LOT 1852516: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENT HAS BEEN REPORTED FOR THIS LOT. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: 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 Ø7MM WAS INSERTED. BASED ON THE INFORMATION COLLECTED THE SURGEON THE TAP. 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. 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 OR EQUIVALENT) 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.

    Description of Event or Problem · 1

    [LUMBAR FIXATION L4 - L5] DURING THE INSERTION OF A SCREW, THE TIP OF THE SCREWDRIVER BROKE. THE OPERATION WAS CONTINUED NORMALLY WITH ANOTHER SCREWDRIVER AND IT WAS SUCCESSFULLY FINISHED WITHOUT ANY DELAY OR ANY ADDITIONAL PROBLEMS. SCREW INVOLVED: 7MM WIDE AND 45MM LONG. THE TAP WAS USED. BONE QUALITY: NORMAL. THE BROKEN TIP WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930513 POLYAXIAL REDUCTION PEDICLE SCREWDRIVER 2.0 CANNULATED SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA 1852516 07630971230767

    Patients

    Seq Age Sex Outcome Treatment
    1 Other