BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.4MM SHRT W/NDLS

    MDR report key: 23594560 · Received November 19, 2025

    Report

    Report Number
    0001825034-2025-03699
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    October 23, 2025
    Report Date
    April 27, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K110145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN - EVENT OCCURRED IN POLAND. POSSIBLE LOTS REPORTED, UNKNOWN AT THIS TIME WHICH LOT IS ASSOCIATED WITH THE EVENT: LOT: 0002438493. MAN: MAY 3, 2022. EXP: MAY 3, 2027. UDI: (B)(4). LOT: 0002722467. MAN: AP 21, 2025. EXP: APR 21, 2030. UDI:(B)(4). LOT: 0002388154. MAN: AUG 24, 2021. EXP: AUG 24, 2026. UDI: (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H2; H3; H6. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD 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 THAT DURING IMPLANTATION, THE TIP OF A DEVICE INSERTER BROKE AND REMAINED IN THE PATIENT. DURING THE IMPLANTATION PROCEDURE, THE GUIDE TIP FRACTURED DURING INSERTION OR WITHDRAWAL AND A FRAGMENT WAS RETAINED. INTRAOPERATIVE RADIOGRAPHIC IMAGING CONFIRMED THE PRESENCE OF THE RETAINED FRAGMENT. NO INFORMATION WAS PROVIDED REGARDING ATTEMPTS TO RETRIEVE THE FRAGMENT OR ADDITIONAL INTRAOPERATIVE MEASURES. THE PATIENT UNDERWENT RADIOGRAPHIC EVALUATION; THE PATIENT OUTCOME IS UNKNOWN. NO REVISION OR REMOVAL HAS BEEN REPORTED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2362322 JUGGERKNOT 1.4MM SHRT W/NDLS FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ZIMMER BIOMET, INC. SEE H11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention