BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOULDER SYSTEM

    MDR report key: 20952231 · Received December 17, 2024

    Report

    Report Number
    3005180920-2024-01019
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 20, 2024
    Report Date
    December 17, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    PMA / PMN Number
    K170452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 DEC 2024 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2024. EXPIRATION DATE: 2029-06-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0163 GLENOID POLYAXIAL NON-LOCKING SCREW - L38 (K170452) LOT. 2346723 BATCH REVIEW PERFORMED ON 02 DEC 2024 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JAN-2024. EXPIRATION DATE: 2029-01-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. INVESTIGATION PERFORMED BY R&D MANAGER: THE SCREW WAS INSERTED IN THE BONE WITH USE OF THE "GLENOID POLYAXIAL SCREWDRIVER - NON-RETENTIVE". THIS, IN CONJUNCTION WITH THE SCLEROTIC BONE, MAY HAVE LED TO OUTWARDS DEFORMATION OF THE SCREW PETALS LEADING TO THE IMPOSSIBILITY TO CONTINUE SCREWING IN THE SCREW. THE SURGICAL TECHNIQUE PRESCRIBES TO USE THIS SCREWDRIVER FOR THE FINAL TIGHTENING ONLY AS OTHER INSTRUMENTS PROVIDED IN THE INSTRUMENT SET ARE DESIGNED TO CONTAIN THE PETALS DURING THE SCREW INSERTION. NO ACTION IS SUGGESTED.

    Description of Event or Problem · 0

    DURING SURGERY, THE GLENOID POLYAXIAL LOCKING SCREW L30 AND L38 COULD NOT BE FULLY INSERTED INTO THE GLENOID BASEPLATE USING THE RESPECTIVE SCREWDRIVER (REF 04.01.10.0284). THE SCREWDRIVER, WHICH WAS USED BOTH FOR INSERTING THE SCREWS AND FOR THE FINAL TIGHTENING, WAS UNABLE TO PROPERLY ENGAGE WITH THE SCREW HEADS DUE TO DEFORMATION CAUSED BY THE APPLIED FORCE DURING INSERTION. AS A RESULT, SUFFICIENT FORCE COULD NOT BE APPLIED TO FULLY INSERT THE SCREWS INTO THE BONE. THE ISSUE OCCURRED IN A RELATIVELY YOUNG PATIENT WITH VERY HARD AND HEALTHY BONE. WHILE ADDITIONAL FORCE WAS REQUIRED TO INSERT THE SCREWS, THIS COULD NOT BE ACHIEVED USING MEDACTA INSTRUMENTS. SPECIFICALLY, THE ROTATION KIT DID NOT OFFER AN OPTION TO CONNECT THE SCREWDRIVER TO THE SCREW WITHOUT RELYING ON THE INDENTS IN THE SCREW HEAD. CONSEQUENTLY, 2 OUT OF 3 SCREWS COULD NOT BE COMPLETELY LOCKED INTO PLACE. 30-MIN DELAY TO TRY GETTING THE SCREWS FURTHER IN/OUT. THE FIRST SCREW WAS INSERTED WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267276 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L30 PHX MEDACTA INTERNATIONAL SA 04.01.0161 2412522

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other