BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUST LT 15MM SHORT - PEDICLE SCREW Ø5X30 CANN

    MDR report key: 16204617 · Received January 19, 2023

    Report

    Report Number
    3005180920-2022-01014
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 22, 2022
    Report Date
    February 23, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971278295
    PMA / PMN Number
    K203482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BZ R&D PROJECT MANAGER DURING VISUAL INSPECTION, ALL DEVICES REPORTED IN THE COMPLAINT HAVE BEEN ANALYZED. THE PEDICLE SCREW HAS BEEN TESTED IN SAWBONES BLOCK AND IT HAS BEEN POSSIBLE TO PERFORM FINAL FIXATION WITHOUT PULLOUT. THE ROOT CAUSE OF THE PULLOUT IS PROBABLY RELATED TO BONE QUALITY. ROD INSERTER LOT. 1856905; THE RELEASE KNOB OF THE ROD INSERTER IS STUCK, EVEN AFTER LUBRICATION IT WAS NOT POSSIBLE TO MOVE IT. A POSSIBLE ROOT CAUSE MAY BE EXCESSIVE FLEXIONAL FORCE APPLIED TO THE SHAFT. ROD INSERTER LOT. 2157010; TIP OF THE INSTRUMENT IS BROKEN AND COMPLETELY MISSING, BECAUSE OF FAILURE OF THE WELDING. A POSSIBLE ROOT CAUSE MAY BE EXCESSIVE FLEXIONAL FORCE APPLIED TO THE SHAFT.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 DECEMBER 2022: LOT 2220315: (B)(4). EXPIRATION DATE: 2027-06-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ADDITIONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON 27 DECEMBER 2022: MIS PEDICLE SCREW 03.52.10.0005 ROD INSERTER BENT SHAFT TYPE 1 LOT 1856905: (B)(4). NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT. LOT 2157010: (B)(4). NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT. INVESTIGATION PERFORMED BY MEDACTA SPINE R&D PROJECT MANAGER: AFTER ROD INSERTION, IT WAS IMPOSSIBLE TO REMOVE ONE OF THE ROD INSERTER BY HANDS SINCE THE HANDLE WAS BLOCKED. IT IS NOT POSSIBLE TO CLEARLY DEFINE THE ROOT CAUSE OF THE FAILURE, ADDITIONAL ANALYSIS WILL BE DONE AS THE PART ARRIVES IN MEDACTA THE OTHER OD INSERTER BROKE DURING THE MANEUVERS TO REMOVE THEM, THE WELDING BROKE ON ONE OF THEM. THE FRAGMENT REMAINED IN THE PATIENT'S BODY. FURTHER INVESTIGATIONS WILL BE DONE AS THE PART ARRIVES IN MEDACTA. IT IS NOT POSSIBLE TO CLEARLY DEFINE WHY THE SCREW GOT LOOSE AND EXITED THE VERTEBRAL BODY, FURTHER ANALYSIS WILL BE DONE AS THE PART ARRIVES IN MEDACTA.

    Description of Event or Problem · 0

    THE PEDICLE SCREW CAME OFF FROM THE VERTEBRAL BODY WHEN THE ROD WAS INSERTED INTO THE SCREW TABS. NO NEW SCREWS WERE INSERTED INTO THE VERTEBRAL BODY AT THIS LEVEL, AND FIXATION WAS PERFORMED ONLY WITH SCREWS AND RODS PLACED AT ANOTHER LEVEL. AFTER INSERTING THE ROD, THE FINAL FASTENING WAS PERFORMED WITH THE SET SCREW. WHEN AN ATTEMPT WAS MADE TO REMOVE THE ROD FROM THE INSERTER, THE LOCKING MECHANISM (HANDLE FOR GRIPPING THE ROD) OF THE INSTRUMENT WAS STUCK AND COULD NOT BE REMOVED. IT WAS FORCEFULLY UNLOCKED WITH PLIERS. ANOTHER ROD WAS THEN USED AND FASTENED WITH THE SET SCREW, WHEN TRYING TO REMOVE THE ROD FROM THE INSERTER THE ROD COULD NOT BE REMOVED AND THE GRIPPING MECHANISM OF THE INSTRUMENT BROKE. THE PART BROKEN REMAINED IN THE PATIENT BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY IN 3.5 HOURS WITH 30 MINUTES OF DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155394 MUST LT 15MM SHORT - PEDICLE SCREW Ø5X30 CANN SPINE PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 03.57.012 2220315 07630971278295

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other