BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE CROCHET HOOK

    MDR report key: 7278647 · Received February 16, 2018

    Report

    Report Number
    0001825034-2018-01093
    Event Type
    Injury
    Date Received
    February 16, 2018
    Date of Event
    January 9, 2018
    Report Date
    May 18, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE PRODUCT CODE - GDG. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. PRODUCT WAS VISUALLY EXAMINED. THE CROCHET HOOK HAS FRACTURED OFF. THE HOOK WAS REPORTED TO HAVE BEEN RETAINED BY PATIENT AND THEREFORE, WAS NOT RETURNED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 · 1

    IT WAS REPORTED THAT THE CROCHET HOOK TIP BROKE OFF INTO THE PATIENT CAUSING THE PATIENT TO RETAIN A FOREIGN OBJECT. AN ATTEMPT AT REMOVAL CAUSED A SIGNIFICANT DELAY GREATER THAN 30 MINUTES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120589 SUTURE CROCHET HOOK HOOK, SURGICAL HWC ZIMMER BIOMET, INC. N/A 691030

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R