BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOGGLELOC WITH ZIPLOOP INLINE

    MDR report key: 17442489 · Received August 2, 2023

    Report

    Report Number
    0001825034-2023-01793
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 28, 2023
    Report Date
    December 14, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDR
    UDI-DI
    00880304567634
    PMA / PMN Number
    K130033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT: 110005087 LOT: 0002411065 TOGGLELOC WITH ZIPLOOP INLINE CAT: 905263 LOT: 221315 COMPOSITCP 60 11X30MM INT SCR 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. 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

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SURGEON THAT ONE OF THE FOUR SUTURE STRANDS RIPPED OFF IN THE PROCESS OF PASSING THE TOGGLELOC AND GRAFT THROUGH THE TUNNELS. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    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
    1385054 TOGGLELOC WITH ZIPLOOP INLINE STAPLE, FIXATION JDR ZIMMER BIOMET, INC. 0002453390 00880304567634

    Patients

    Seq Age Sex Outcome Treatment
    1 Male