BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSEPH DOUBLE HOOK 5MM

    MDR report key: 7206053 · Received January 19, 2018

    Report

    Report Number
    9611112-2018-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    September 26, 2017
    Report Date
    January 19, 2018
    Manufacturer
    HEBUMEDICAL GMBH
    Product Code
    GDG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITH THE BROKEN-OFF TIP. IT HAD BEEN MANUFACTURED IN AUGUST 2011. REVIEW OF MANUFACTURING RECORDS CONFIRMED DEVICE CONFORMANCE TO SPECS AT TIME OF RELEASE. HARDNESS OF RETURNED DEVICE WAS TESTED AND FOUND CONFORMING TO SPECIFICATIONS. THE DEVICE WAS SUBJECT TO MICROSCOPIC EXAMINATION. IT SHOWED EVIDENCE OF EXTENSIVE REUSE, SUCH AS WEAR, SCRATCHES, AND STAINING IN THE FRACTURE AREA. THEREFORE, FRACTURE DUE TO EXCESSIVE WEAR AND TEAR SEEMS TO BE THE MOST PROBABLE CAUSE.

    Description of Event or Problem · 1

    DURING AN OPEN REDUCTION WITH INTERNAL FIXATION OF THE RIGHT INDEX FINGER, THE TIP OF THE INSTRUMENT BROKE OFF. THE BROKEN PIECE WAS RETRIEVED. NO DELAY OR INJURY DURING CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48340 JOSEPH DOUBLE HOOK 5MM HOOK GDG HEBUMEDICAL GMBH 48 118

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention