BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE FOR 6.5MM SCREW DRILL TIP THREADED TIP 3.0 X 300MM

    MDR report key: 11884239 · Received May 26, 2021

    Report

    Report Number
    3008951116-2021-00004
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 26, 2021
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HTY
    UDI-DI
    05055662956344
    PMA / PMN Number
    K163489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INVESTIGATION, THE ROOT CAUSE FOR THE WIRE FRACTURE WAS UNABLE TO DEFINITIVELY ASCERTAINED DUE TO A LACK OF CLINICAL USE INFORMATION AND THE COMPLAINT DEVICE NOT BEING RETURNED FOR VISUAL INSPECTION TO CHARACTERISE THE NATURE OF THE DEVICE FRACTURE. REVIEW OF THE DHRS FOR THE REPORTED BATCHES VERIFIED THAT THE WIRE WAS SUPPLIED IN CONFORMANCE TO THE SPECIFICATIONS. NO DEVIATIONS WERE NOTED WHICH MAY HAVE CONTRIBUTED TO THE FAILURE OF THE DEVICE IN ITS INTENDED USE. TREND ANALYSIS FOR THE WIRE SHOWED THAT THIS WAS THE FIRST COMPLAINT REPORTED, AND THE FAILURE RATE IS DEEMED AS LOW AND NO NEGATIVE TREND FOR THIS K-WIRE HAS BEEN NOTED.

    Description of Event or Problem · 1

    DURING A SUBTALAR FUSION, THE TIP OF THE GUIDE WIRE BROKE AND WAS LEFT INSIDE THE BONE. NO PATIENT INJURY WAS REPORTED AT THIS TIME. FURTHER INFORMATION HAD BEEN REQUESTED FROM THE INITIAL REPORTER, HOWEVER NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THE TIME OF THIS REPORT AND NO FURTHER COMPLICATIONS OR ADVERSE SURGICAL OUTCOMES HAVE BEEN REPORTED. SHOULD ORTHO SOLUTIONS RECEIVE UPDATED INFORMATION WHICH CHANGES THE OVERALL HEALTH IMPACT AS DOCUMENTED HERE, THIS REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782563 K-WIRE FOR 6.5MM SCREW DRILL TIP THREADED TIP 3.0 X 300MM ORTHOPAEDIC BONE WIRE HTY ORTHO SOLUTIONS UK LTD OS900032-S 1111280 05055662956344

    Patients

    Seq Age Sex Outcome Treatment
    1