BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT SOFT ANCHORS SHORT MAXBRAID - BLUE/WHITE WITH NEEDLES

    MDR report key: 19746507 · Received July 15, 2024

    Report

    Report Number
    0001825034-2024-01840
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 27, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K110145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4/H4: IT WAS REPORTED THAT THE EXACT LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. HOWEVER, THERE ARE THREE (3) POTENTIAL LOT NUMBERS OF THE DEVICE INVOLVED. THESE ARE LISTED BELOW WITH THEIR ASSOCIATED DATES OF MANUFACTURE, EXPIRATION DATES, AND UDIS. POTENTIAL LOT (1): 0002504256. - MANUFACTURING DATE: 3/8/2023. - EXPIRATION DATE: 3/8/2028. - UDI: (B)(4). POTENTIAL LOT (2): 0002561272. - MANUFACTURING DATE: 10/25/2023. - EXPIRATION DATE: 10/25/2028. - UDI: (B)(4). POTENTIAL LOT (3): 415040. - MANUFACTURING DATE: 4/15/2021. - EXPIRATION DATE: 4/15/2026. - UDI: (B)(4). G2: FOREIGN - THE EVENT OCCURRED IN JAPAN. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 REPORTED EVENT IS CONFIRMED BY RETURNED PRODUCT. VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED THE DEVICE WAS RETURNED WITHOUT THE SUTURES, NEEDLES AND THE IMPLANT. THE TIP OF THE DEVICE HAS FRACTURED AND WAS NOT RETURNED. FRACTURE ANALYSIS HAS BEEN PREVIOUSLY ANALYZED IN AN INTERNAL MEMO WHERE BENDING OVERLOAD WAS IDENTIFIED AS THE MODE OF FAILURE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, THE TIP OF THE INSERTER WAS FRACTURED WHILE THE SURGEON IMPLANTED THE ANCHOR INTO THE PATIENT'S BURR HOLE. THE SURGEON NOTED THAT THE ANCHOR COULDN'T BE INSERTED INTO THE PATIENT'S BURR HOLE SMOOTHLY, AND THE PATIENT RETAINED THE TIP OF THE INSERTER. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    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
    2518174 JUGGERKNOT SOFT ANCHORS SHORT MAXBRAID - BLUE/WHITE WITH NEEDLES FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other