BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JGRKNT SINGLE 1.4MM 1 #1 MB

    MDR report key: 16428287 · Received February 23, 2023

    Report

    Report Number
    0002648920-2023-00022
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    January 19, 2023
    Report Date
    August 2, 2023
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    MBI
    UDI-DI
    00880304477193
    PMA / PMN Number
    K150768
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORT: 0002648920-2023-00023. CONCOMITANT MEDICAL PRODUCTS: ITEM#: 912030; LOT#: P15222. REPORT SOURCE: FOREIGN - EVENT OCCURRED IN POLAND. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANTATION, THE IMPLANT DID NOT STAY IN THE BONE AND THE THREAD BROKE WHILE BEING TIGHTENED. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448626 JGRKNT SINGLE 1.4MM 1 #1 MB FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ZIMMER MANUFACTURING B.V. NI P15213 00880304477193

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose