BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEWIN SPINAL PERFORATING FORCEPS

    MDR report key: 11805433 · Received May 11, 2021

    Report

    Report Number
    9611112-2021-00001
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    February 17, 2021
    Report Date
    May 11, 2021
    Manufacturer
    HEBUMEDICAL GMBH
    Product Code
    GEN
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS A NEUROSURGICAL FORCEPS INTENDED FOR USE ON THE SPINE. HOWEVER, WHEN THE REPORTED EVENT OCCURRED THE DEVICE WAS BEING USED DURING AN ORTHOPEDIC PROCEDURE TO REMOVE THE HEAD OF THE FEMUR, AN INTERVENTION REQUIRING A FORCE MUCH GREATER THAN THE USE INTENDED BY THE MANUFACTURER. REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY RELATED ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED PROBLEM AND DEVICE CONFORMANCE TO SPECS AT TIME OF RELEASE WAS CONFIRMED. HARDNESS OF THE RETURNED DEVICE WAS TESTED AND FOUND CONFORMING TO SPECIFICATIONS. IT CAN BE CONCLUDED THAT INAPPROPRIATE USE OF THE DEVICE BY APPLICATION OF EXCESSIVE FORCE AND FOR AN INTENDED USE DIFFERENT THAN THE ONE SPECIFIED BY THE MANUFACTURER LIKELY CAUSED BREAKAGE OF THE DEVICE.

    Description of Event or Problem · 1

    THE HEALTHCARE FACILITY REPORTED THAT THE CLAMP JAWS BROKE WHILE BEING UTILIZED TO REMOVE THE HEAD OF THE FEMUR DURING THE SURGICAL CASE. THE BROKEN-OFF PART OF THE JAWS WAS RETRIEVED USING A C-ARM. NO PATIENT INJURY KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706480 LEWIN SPINAL PERFORATING FORCEPS SPINAL FORCEPS OR CLAMP GEN HEBUMEDICAL GMBH XHE 1P

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention