BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERSTITCH MENISCAL REPAIR DEVICE CURVED

    MDR report key: 22060484 · Received May 21, 2025

    Report

    Report Number
    0001825034-2025-01471
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 30, 2025
    Report Date
    September 10, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    UDI-DI
    00880304690073
    PMA / PMN Number
    K191459
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# 110024773N; LOT# 0930581. ITEM# 110027358; LOT# 706560. ITEM# 110024773; LOT# 66981736. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE HOSPITAL DISCARDED IT. 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.

    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. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE PART AND LOT NUMBER OF THE COMPLAINT PART AND THAT THE NEEDLE WAS BROKEN OFF THE ASSEMBLY. 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. THE REPORTED EVENT IS CONFIRMED AS A PICTURE WAS PROVIDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON TOGGLED THE ANCHOR AND UPON THE FIRST STICK, PULLED BACK AND THE TIP BROKE OFF. THE TIP WAS RETRIEVED WITH A GRASPER WITHIN 1 MINUTE. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78654 JUGGERSTITCH MENISCAL REPAIR DEVICE CURVED FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ZIMMER BIOMET, INC. NI 66971693 00880304690073

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male SEE NARRATIVE IN H11.