BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI LOW PROFILE SCREW 6.5X20MM

    MDR report key: 8409805 · Received March 11, 2019

    Report

    Report Number
    0001825034-2019-01082
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    November 14, 2018
    Report Date
    March 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K971890
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: (46) 103531 ¿ TI LOW PROFILE SCREW ¿ 860850. (8) 103533 ¿ TI LOW PROFILE SCREW ¿ 860850. REPORT SOURCE (B)(6). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DIMENSIONAL ANALYSIS WAS CONDUCTED ON THREE PIECES OF EACH SIZE AND CONFIRMS THAT THE ITEM NUMBER 103533 MEASURES AS 20MM AND THE ITEM NUMBER 103531 MEASURES AS 30MM. VISUAL INSPECTION WAS CONDUCTED ON THE REMAINING RETURNED PRODUCT AND FOUND THAT ALL RETURNED 30MM SCREWS MEASURED AS 20MM AND ALL RETURNED 20MM SCREWS MEASURED AS 30MM. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE MANUFACTURING PROCESS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01080, 0001825034 - 2019 - 01081, 0001825034 - 2019 - 01083.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE SCREWS LABELED AS BEING 20MM IN LENGTH ACTUALLY MEASURED AS BEING 30MM IN LENGTH AND THE SCREWS LABELED 30MM IN LENGTH ACTUALLY MEASURED AS BEING 20MM IN LENGTH. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202427 TI LOW PROFILE SCREW 6.5X20MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 860850

    Patients

    Seq Age Sex Outcome Treatment
    1