BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERSTITCH CURVED IMPLANT

    MDR report key: 17020053 · Received May 30, 2023

    Report

    Report Number
    0001825034-2023-01177
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    April 28, 2023
    Report Date
    November 22, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K191459
    Removal / Correction Number
    N/A
    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). UPDATE TO MANUFACTURING DATE AND UDI OF POSSIBLE LOT # 65867729 MGF DATE: JAN 31, 2023 UDI: (B)(4). REPORTED EVENT WAS CONFIRMED AS VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED NO ETCH ON THE PIECE RETURNED AND NO PACKAGING WAS RETURNED. ONLY A FRACTURED OFF PORTION OF THE NEEDLE WAS RETURNED AND APPEARED BENT NEAR THE TIP OF THE NEEDLE. FRACTURE ANALYSIS WAS PREVIOUSLY ANALYZED WHERE BENDING OVERLOAD WAS IDENTIFIED AS THE MODE OF FAILURE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE PART/LOT INFORMATION COULD BE: D4 - LOT NUMBER - 65867729 ; D4 - EXPIRATION DATE - JAN 31, 2028; H4 - MANUFACTURE DATE ¿ MAR 03, 2023; H4 - UDI - (B)(4). OR THE PART/LOT INFORMATION COULD BE: D4 - LOT NUMBER - 060260; D4 - EXPIRATION DATE - FEB 11, 2026; H4 - MANUFACTURE DATE ¿ FEB 11, 2021; H4 - UDI - (B)(4). H3: 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. H3 OTHER TEXT : WILL BE RETURNED BUT NOT YET.

    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 THE SURGERY, THE NEEDLE OF THIS DEVICE WAS FRACTURED AND THE FRACTURED PIECE OF NEEDLE REMAINED IN THE PATIENT'S BODY TEMPORARILY. THE PATIENT'S WOUND WAS SURGICALLY CLOSED THEN IT WAS FOUND THAT THE PIECE OF NEEDLE WAS STILL INSIDE THE PATIENT. THE SURGEON RE-OPENED THE PATIENT AND REMOVED THE FRACTURED NEEDLE PIECE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449050 JUGGERSTITCH CURVED IMPLANT SPORTS MED IMPLANTS MBI ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H