BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEWIN BONE HOLD CLAMP 7 / DISCONTINUED-ALT NL6960-1

    MDR report key: 7662093 · Received July 4, 2018

    Report

    Report Number
    9611112-2018-00004
    Event Type
    Malfunction
    Date Received
    July 4, 2018
    Date of Event
    April 23, 2018
    Report Date
    July 4, 2018
    Manufacturer
    HEBUMEDICAL GMBH
    Product Code
    HXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION AND BREAKAGE OF DEVICE WAS CONFIRMED. IT HAD BEEN MANUFACTURED IN APRIL 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. NO PRODUCT PROBLEMS COULD BE DETECTED. INAPPROPRIATE USE OF THE DEVICE BY APPLICATION OF EXCESSIVE FORCE TO THE TIPS OF THE INSTRUMENT MAY HAVE CAUSED THE FRACTURE. BUT SINCE NO FURTHER INFORMATION ABOUT THE SURGERY PERFORMED WAS PROVIDED, HUMAN FACTORS ISSUE CANNOT BE CONFIRMED AND IT IS NOT POSSIBLE TO REACH A DEFINITE CONCLUSION WITH REGARD TO THE CAUSE OF THE FRACTURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TIP BROKE WHILE BEING UTILIZED DURING A SURGERY. NO PATIENT INJURY NOR INTERVENTION WAS REPORTED. THERE WERE NO X-RAYS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504804 LEWIN BONE HOLD CLAMP 7 / DISCONTINUED-ALT NL6960-1 CLAMP HXD HEBUMEDICAL GMBH XHER04

    Patients

    Seq Age Sex Outcome Treatment
    1