BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L34

    MDR report key: 18019680 · Received October 27, 2023

    Report

    Report Number
    3005180920-2023-00828
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Date of Event
    September 29, 2023
    Report Date
    October 27, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706490
    PMA / PMN Number
    K170452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA SHOULDER R&D PROJECT MANAGER ON 24 OCTOBER 2023: THE PRONGS ARE CONFIRMED TO BE MASSIVELY DEFORMED. GIVEN THE ENTITY AND THE TYPE OF DAMAGE, THE DEFORMATION LIKELY OCCURRED DURING THE SCREW REMOVAL WITH USE OF A CLAMP. THE ROOT CAUSE IS IDENTIFIED IN THE USE OF THE WRONG INSTRUMENT, "GLENOID POLYAXIAL SCREWDRIVER - NON-RETENTIVE", FOR THE SCREW INSERTION. NO ACTION IS SUGGESTED. BATCH REVIEW PERFORMED ON 03 OCTOBER 2023: LOT 2246832: 49 ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2023. EXPIRATION DATE: 2028-01-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 35 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 03 OCTOBER 2023 REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452) LOT 2304638: 70 ITEMS MANUFACTURED AND RELEASED ON 14-APR-2023. EXPIRATION DATE: 2028-03-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 52 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    DURING THE SURGERY, THE PRONGS OF TWO GLENOID POLYAXIAL SCREWS WERE DEFORMED, DURING THE INSERTION PHASE WHILE USING THE GLENOID POLYAXIAL SCREWDRIVER - NON-RETENTIVE. THE BONE WAS HARD. THE GLENOID POLYAXIAL LOCKING SCREW - L26 WAS REPLACED WITH ANOTHER SCREW, WHILE THE GLENOID POLYAXIAL LOCKING SCREW - L34 WAS REAMED DOWN WITH AIRTOME CUTTER. DELAY TIME WAS 40 - 50 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150262 REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L34 SHOULDER GLENOID POLYAXIAL SCREW PHX MEDACTA INTERNATIONAL SA 2246832 07630040706490

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other