BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLE THREADS INTERFERENCE SCREW FULL THREAD

    MDR report key: 20130505 · Received September 3, 2024

    Report

    Report Number
    0001825034-2024-02145
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 8, 2024
    Report Date
    January 16, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    UDI-DI
    00880304003255
    PMA / PMN Number
    K041274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): 905257 (240534). G2: FOREIGN - THE EVENT OCCURRED IN UNITED ARAB EMIRATES. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6; H10. THE REPORTED EVENT IS NOT CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B1; B2; B4; B5; D2; D6; G1; G3; G6; H1; H2; H6. CORRECTIONS TO B1; B2; B5; D6; H1; H2, AS THE PATIENT DID NOT RETAIN THIS PRODUCT, ADDITIONAL INFORMATION INDICATED THE RETAINED SCREW WAS PART NUMBER 905257. 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 THAT DURING AN INITIAL PROCEDURE, TWO INTERFERENCE SCREWS FRACTURED. HALF OF ONE SCREW REMAINS IN THE PATIENT'S BONE TUNNEL. THE SURGEON INDICATED THAT IT WAS NOT POSSIBLE TO REMOVE IT. THE CORRECT SURGICAL TECHNIQUE WAS USED. NO OTHER COMPLICATIONS OR IMPACTS WERE REPORTED DUE TO THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL HAMSTRING TENDON GRAFT PROCEDURE, TWO INTERFERENCE SCREWS FRACTURED. HALF OF ONE SCREW REMAINS IN THE PATIENT'S BONE TUNNEL AND IS INDICATED TO BE STABLE WITHOUT THE POTENTIAL FOR MIGRATION. THE SURGEON STATED THAT REMOVING IT WAS NOT POSSIBLE, AND THE CASE WAS COMPLETED WITH A BONE POST OUTSIDE THE TUNNEL FOR GRAFT FIXATION. THE CORRECT SURGICAL TECHNIQUE WAS USED. NO OTHER COMPLICATIONS OR IMPACTS WERE REPORTED DUE TO THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899940 GENTLE THREADS INTERFERENCE SCREW FULL THREAD SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER HWC ZIMMER BIOMET, INC. NI 544900 00880304003255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other H11