BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 26 K-WIRE FOR 4.0MM SCREW DRILL TIP THREADED TIP 1.6X150MM

    MDR report key: 11567192 · Received March 25, 2021

    Report

    Report Number
    3008951116-2021-00002
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    February 20, 2021
    Report Date
    March 25, 2021
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HTY
    UDI-DI
    05055662956030
    PMA / PMN Number
    K163489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WIRE WAS NOT RETURNED, THUS VISUAL INSPECTION COULD NOT BE UNDERTAKEN. NO FUTHER CLINICAL INFORMATION OR IMAGING WAS AVAILABLE, THUS THE INVESTIGATION WAS LIMITED TO INTERNAL REVIEWS. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE PRODUCT WAS SUPPLIED IN CONFORMANCE WITH ORTHO SOLUTIONS SPECIFICATIONS. A WIRE FROM THE SAME BATCH WAS PREVIOUSLY TESTED UNDER WORST-CASE CONDITIONS, AND THE DEVICE PERFORMED AS INTENDED AND FULFILLED THE ACCEPTANCE CRITERIA WITH NO DEVIATIONS. THE ROOT CAUSE FOR THE COMPLAINT CONDITION COULD NOT BE ASCERTAINED FOLLOWING THE INVESTIGATION, HOWEVER THE MANUFACTURE OF THE WIRE WAS NOT LIKELY TO BE THE CONTRIBUTORY CAUSE FOR THE ISSUE. THE COMPLAINT DOES NOT SUGGEST ANY NEW OR EMERGING RISKS WITH THE DEVICE WHEN UTILISED IN ACCORDANCE TO ITS INTENDED USE.

    Description of Event or Problem · 1

    DURING AN ORIF ANKLE PROCEDURE, WHERE THE PATIENT REQUIRED TWO CANNULATED SCREWS BI-MALLEOLAR, IT WAS REPORTED THAT THE K-WIRE BROKE UPON INSERTION AND RETAINED IN THE PATIENT. THE REMNANT PORTION OF THE WIRE WAS DISCARDED BY THE HEALTHCARE FACILITY. THE SURGICAL PROCEDURE PROCEEDED SUCCESSFULLY, AND NO PATIENT INJURY WAS REPORTED. NO FURTHER COMPLICATIONS WHICH REQUIRED MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467222 SYSTEM 26 K-WIRE FOR 4.0MM SCREW DRILL TIP THREADED TIP 1.6X150MM ORTHOPAEDIC BONE WIRE HTY ORTHO SOLUTIONS UK LTD OS900030-S 1A2478 05055662956030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other