BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEWIN BONE HOLD CLAMP 7

    MDR report key: 7057920 · Received November 24, 2017

    Report

    Report Number
    9611112-2017-00005
    Event Type
    Malfunction
    Date Received
    November 24, 2017
    Date of Event
    August 29, 2017
    Report Date
    November 24, 2017
    Manufacturer
    HEBUMEDICAL GMBH
    Product Code
    GDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF THE DEVICE WAS REQUESTED, BUT IT HAD BEEN SCRAPPED AND WAS THEREFORE NOT AVAILABLE FOR EVALUATION AND TESTING. EVALUATION WAS BASED ON A PHOTOGRAPH OF THE DAMAGED DEVICE AND MANUFACTURING RECORDS. IT WAS MANUFACTURED IN JULY 2016. REVIEW OF MANUFACTURING RECORDS CONFIRMED DEVICE CONFORMANCE TO SPECS AT TIME OF RELEASE. THE PHOTOGRAPH OF THE DEVICE CONFIRMED BREAKAGE OF THE TIP AND SIGNS OF WEAR. INAPPROPRIATE USE OF THE DEVICE BY APPLICATION OF EXCESSIVE FORCE TO THE TIPS OF THE INSTRUMENT MAY HAVE CAUSED THE FRACTURE. HOWEVER, SINCE THE DEVICE WAS NOT RETURNED IT IS NOT POSSIBLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS FAILURE.

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE LEWIN CLAMP DURING A RIGHT TOTAL HIP ARTHROPLASTY TO CLAMP DOWN ON PATIENT'S BONE AND THE ENTIRE TIP BROKE OFF. THE BROKEN PIECE WAS RETRIEVED. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837143 LEWIN BONE HOLD CLAMP 7 CLAMP GDJ HEBUMEDICAL GMBH 100088-1607

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention