BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE CROCHET HOOK

    MDR report key: 10546148 · Received September 17, 2020

    Report

    Report Number
    0001825034-2020-03551
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    September 8, 2020
    Report Date
    February 2, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    GDG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. A CONTRIBUTING FACTOR COULD BE THE MENTION OF TOO MUCH PRESSURE, HOWEVER, THAT WAS UNABLE TO BE CONFIRMED AND THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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

    NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE PRODUCT CODE: GDG. UDI#: (B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END TIP OF THE SUTURE CROCHET HOOK WAS BROKEN DURING THE SURGERY. THE REASON WAS DUE TO MUCH PRESSURE. ANOTHER SUTURE INSTRUMENT WAS USED TO COMPLETE THE SURGERY. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016230 SUTURE CROCHET HOOK HOOK, SURGICAL GDG ZIMMER BIOMET, INC. 785340

    Patients

    Seq Age Sex Outcome Treatment
    1