BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEWIN BONE HOLD CLAMP 7

    MDR report key: 6449076 · Received March 31, 2017

    Report

    Report Number
    9611112-2017-00001
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Report Date
    March 31, 2017
    Manufacturer
    HEBUMEDICAL GMBH
    Product Code
    HXD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITHOUT THE BROKEN-OFF TIP. IT HAD BEEN MANUFACTURED IN 2012. 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. SINCE THE DEVICE WAS RETURNED INCOMPLETE, I.E., WITHOUT THE BROKEN-OFF TIP, IT IS NOT POSSIBLE TO REACH A DEFINITE CONCLUSION WITH REGARD TO THE CAUSE OF THE FRACTURE. HOWEVER, FRACTURE DUE TO EXCESSIVE WEAR AND TEAR SEEMS TO BE THE MOST PROBABLE CAUSE.

    Description of Event or Problem · 1

    DURING AN OPEN REDUCTION (INTERNAL FIXATION OF THE PROXIMAL HUMERUS), THE TIP OF THE INSTRUMENT BROKE OFF. THE BROKEN PIECE WAS RETRIEVED. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232056 LEWIN BONE HOLD CLAMP 7 CLAMP HXD HEBUMEDICAL GMBH 139431

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention