BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMP NLK SCR 3.5HEX 4.75X35 ST

    MDR report key: 14462277 · Received May 20, 2022

    Report

    Report Number
    0001825034-2022-01259
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    December 1, 2021
    Report Date
    May 19, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304677289
    PMA / PMN Number
    K132239
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). YEAR OF BIRTH: (B)(6). CONCOMITANT MEDICAL PRODUCTS: 180563 187570 COMP NLK SCR 3.5HEX 4.75X45 ST 110040301 750520 COMPR AUG MINI 3.5 HEX DRIVER 110010424 783980 COMP RVS 3.5MM HEX DRIVER. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). THE DEVICE WAS RECEIVED AND SUBMITTED FOR ANALYSIS. SEM ANALYSIS DETERMINED THAT THE COMP NON-LOCKING SCREW SAMPLE FRACTURED DUE TO TORSIONAL OVERLOAD. SUSPECTED CRACK INITIATION REGION IDENTIFIED ON THE FRACTURE SURFACE. SHEARED DUCTILE OVERLOAD DIMPLES IDENTIFIED NEAR THE CRACK INITIATION REGION. FRACTURE SHOWED TORSIONAL OVERLOAD MODE OF FRACTURE THROUGHOUT EXHIBITING SHEARED DUCTILE DIMPLES. EDS SEMI-QUANTITATIVE ELEMENTAL ANALYSIS OF THE NON-LOCKING SCREW SHOWED THAT IT WAS CONSISTENT WITH TI-6AL-4V ALLOY. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN INSERTING THE INFERIOR SCREW, THE SCREW COULD NOT BE FULLY COUNTERSUNK. REMOVING THE SCREW WAS ALSO DIFFICULT. PLIERS FROM THE OPERATING ROOM HAD TO BE USED BECAUSE THE SCREWDRIVERS DID NOT GRIP THE SCREW HEAD. A DEFECT IN THE SCREWDRIVER COULD HAVE BEEN THE CAUSE. WHEN INSERTING THE SUPERIOR SCREW, THE SCREW HEAD GOT BROKEN. THE REST OF THE SCREW WAS LEFT IN PLACE AND THE REMAINING 3 PERIPHERAL SCREW HOLES WERE FILLED. ALL SCREW HOLES WERE ADEQUATE IN DEPTH. THE SCREW WAS RETURNED FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION, ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519068 COMP NLK SCR 3.5HEX 4.75X35 ST PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 792670 00880304677289

    Patients

    Seq Age Sex Outcome Treatment
    1 Male