BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOHMANN RETRTR,9.75" LGX 19MM WD BLADE

    MDR report key: 19469583 · Received June 5, 2024

    Report

    Report Number
    1220246-2024-04951
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    July 15, 2022
    Report Date
    June 5, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867138513
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO IMPROPER DETERGENT/CLEANING PROCESS USED.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 07/15/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-9260-48 HOHMANN RETRACTOR CAME OUT OF STERILIZATION DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524261 HOHMANN RETRTR,9.75" LGX 19MM WD BLADE RETRACTOR MDM ARTHREX, INC. HOHMANN RETRTR,9.75" LGX 19MM WD BLADE 00888867138513

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown