BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOULDER GENERAL GLENOID POLYAXIAL SCREWDRIVER - NON-RETENTIVE

    MDR report key: 12868652 · Received November 24, 2021

    Report

    Report Number
    3005180920-2021-00916
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    October 27, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630971211902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. ONE PRONG IS CONFIRMED TO BE BROKEN. THE SCREWDRIVER SHAFT WAS MANUFACTURED IN AISI 420 MOD AS PER DRAWING REVISION IN FORCE AT THE TIME OF PRODUCTION. THE MATERIAL WAS MODIFIED FROM AISI 420 MOD TO AISI 420 B IN ORDER TO IMPROVE THE MECHANICAL RESISTANCE OF THE INSTRUMENT AND PREVENT FURTHER OCCURRENCE OF SUCH EVENTS. THE GLENOSPHERE DOES NOT SHOW ANY SIGNS OF DAMAGE OR DISCOLOURATION. THE GLENOSPHERE SCREW SHOWS CIRCULAR SCRATCHES ON THE OUTER SURFACE OF BOTH THE SCREW HEAD AND THE MAIN SHAFT. IN ADDITION THE THREAD IS DAMAGED, LIKELY DUE TO MALALIGNMENT WHILE TIGHTENING THE SCREW. IT IS NOT POSSIBLE TO DETERMINE WHETHER THE GLENOSPHERE WAS INCORRECTLY SEATED ON THE BASEPLATE DUE TO THE PRESENCE OF THE FRAGMENT. WITH THE INFORMATION AT HAND, IT IS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE OF THE EVENT. BATCH REVIEW PERFORMED ON 19 NOVEMBER 2021. LOT 1854513: 32 ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 3 SIMILAR EVENTS HAVE BEEN REPORTED ON THIS LOT. ADDITIONAL COMPONENT INVOLVED IN THE EVENT: REVERSE SHOULDER SYSTEM 04.01.0167 GLENOSPHERE 32XØ22 (K170452) LOT. 189859. LOT 189859: 79 ITEMS MANUFACTURED AND RELEASED ON 10-APR-2019. EXPIRATION DATE: 2024-03-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO ITEMS OF THE SAME LOT HAVE BEEN SOLD.

    Description of Event or Problem · 0

    THE SURGEON HAD DIFFICULTY IMPLANTING THE GLENOSPHERE. LOOKING AT THE X-RAYS, A FRAGMENT OF THE SCREWDRIVER WAS NOTICED. THE SURGEON REMOVED THE FRAGMENT AFTER REMOVING THE IMPLANT. A NEW GLENOSPHERE WAS USED TO COMPLETE THE SURGERY. THERE WAS A 30 MINUTES DELAY, TOTAL SURGERY TIME 130 MINUTES. ALSO, THE GLENOSPHERE SCREW THREAD WAS DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770526 SHOULDER GENERAL GLENOID POLYAXIAL SCREWDRIVER - NON-RETENTIVE INSTRUMENT FOR SHOULDER SURGERY LXH MEDACTA INTERNATIONAL SA 04.01.10.0284 1854513 07630971211902

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other