BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMAX DUAL OFFSET BROACH HANDLE RIGHT

    MDR report key: 7181342 · Received January 10, 2018

    Report

    Report Number
    3004641308-2017-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Date of Event
    October 20, 2017
    Report Date
    January 11, 2018
    Manufacturer
    ENZTEC LIMITED
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PREVIOUSLY REPORTED TO FDA BY (B)(4) (DISTRIBUTOR) ON REPORT #3008021110-2017-00112. DEVICE NOT YET RETURNED FOR EVALUATION, HOWEVER THE DISTRIBUTOR NOTES THAT THE PROBLEM COULD BE MORE RELATED TO THE BROACH USED (WHICH IS NOT MANUFACTURED BY ENZTEC LIMITED) OR THE SURGICAL TECHNIQUE, RATHER THE BROACH HANDLE. COMPLAINT CANNOT BE SUBSTANTIATED AND EVENT CANNOT BE ATTRIBUTED TO THE BROACH HANDLE UNTIL RETURNED FOR EVALUATION. NOTE ALSO THAT THIS REPORT WAS ATTEMPTED TO BE SUBMITTED BY ENZTEC LIMITED ON 12TH DECEMBER 2017, BUT IT HAS TAKEN 1 MONTH TO HAVE THE APPROPRIATE ACCOUNTS SET UP TO ALLOW ELECTRONIC SUBMISSION.

    Description of Event or Problem · 1

    INTRA OPERATIVE MALFUNCTION OF THE BROACH HANDLE - CODE# 9095.11.002, LOT# 15AE004B - EXPERIENCED DURING A HIP SURGERY PERFORMED. ON (B)(6) 2017. ACCORDING TO THE INFORMATION REPORTED, THE BROACH HANDLE DISCONNECTED FROM THE BROACH WHEN REMOVING BROACH FROM FEMORAL CANAL. SURGERY TIME REPORTEDLY PROLONGED 25 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24663 HMAX DUAL OFFSET BROACH HANDLE RIGHT DUAL OFFSET BROACH HANDLE LXH ENZTEC LIMITED 9095.11.002 15AE004B

    Patients

    Seq Age Sex Outcome Treatment
    1