BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX

    MDR report key: 2190792 · Received July 28, 2011

    Report

    Report Number
    MW5021585
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ARTHREX MED. INST. GMBH
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUTURE MITT-ARTHREX. TIP APPROX 1-2MM BROKE OFF DURING PROCEDURE IN PT'S SHOULDER AND COULD NOT BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX NEEDLE, MULTIFIRE SCORPION WITH SUTURE MITT HRX ARTHREX MED. INST. GMBH 409680

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR