BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERSTITCH CURVED IMPLANT

    MDR report key: 18885553 · Received March 12, 2024

    Report

    Report Number
    0001825034-2024-00691
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    February 22, 2024
    Report Date
    August 26, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    UDI-DI
    00880304690073
    PMA / PMN Number
    K191459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4/H4 CORRECTION: 2 LOT COMBINATIONS ARE AVAILABLE FOR THIS DEVICE: MANUFACTURING DATES: LOT 66111189 - 7/14/2023. LOT 66196178 - 9/22/2023. STERILE EXPIRATION DATES: LOT 66111189 - 7/14/2028. LOT 66196178 - 9/22/2028. UDIS: LOT 66111189: (B)(4). LOT 66196178: (B)(4). VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED THE DEVICE WAS RETURNED WITH THE SHRINK FILM OPEN. THE DEVICE WAS CYCLED 1 TIME AND POSSIBLY A PARTIAL CYCLE. THE FIRST ANCHOR WAS ALSO OUT OF THE NEEDLE WHEN WE RECEIVED THE PRODUCT. WAS ABLE TO CYCLE THE PUSHER ASSEMBLY A SECOND TIME AND THERE WERE NO ISSUES WITH THE SECOND ANCHOR DEPLOYING FROM THE NEEDLE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS CONFIRMED BY RETURNED PRODUCT. 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

    (B)(4). G2: JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BOTH ANCHORS OF THE DEVICE WAS UNABLE TO BE DEPLOYED AS INTENDED. AN ALTERNATIVE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANCHOR OF THE DEVICE WAS UNABLE TO BE DEPLOYED AS INTENDED. AN ALTERNATIVE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028298 JUGGERSTITCH CURVED IMPLANT SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE MBI ZIMMER BIOMET, INC. NI 66111189 OR 66196178 00880304690073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose