BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEG HOLDER, LOW PROFILE

    MDR report key: 19791799 · Received July 22, 2024

    Report

    Report Number
    1220246-2024-06812
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 25, 2024
    Report Date
    August 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    BWN
    UDI-DI
    00888867018204
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTIONS: H.1 SET AS N/A. ARTHREX PREVIOUSLY SUBMITTED THIS EVENT AS A REPORTABLE MALFUNCTION OUT OF AN ABUNDANCE OF CAUTION. UPON FURTHER REVIEW AND EVALUATION OF ASSOCIATED RISK DOCUMENTATION, IT HAS BEEN DETERMINED THAT THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER 21 CFR 803.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, ACCORDING TO PICTURES, THE LEG HOLDER SHOWS SIGNS OF WEAR AND TEAR. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

    Description of Event or Problem · 0

    UPDATE, (KHE), (B)(6) 2024 FURTHER INFORMATION RECEIVED. THE EVENT WAS OCCURRED DURING THE REPROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025735 LEG HOLDER, LOW PROFILE OPERATING ROOM TABLE ACCESS BWN ARTHREX, INC. LEG HOLDER, LOW PROFILE 00301.14 00888867018204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown