BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-WIRE TROCAR TIP 2.0MM X 150MM

    MDR report key: 10611728 · Received October 1, 2020

    Report

    Report Number
    3008951116-2020-00008
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    September 3, 2020
    Report Date
    October 1, 2020
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HTY
    UDI-DI
    05055662923124
    PMA / PMN Number
    K110895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE FOR THE WIRE FRACTURE WAS UNABLE TO BE ASCERTAINED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE BATCH REVEALED THAT THE DEVICES WERE SUPPLIED IN CONFORMANCE WITH PRE-DETERMINED SPECIFICATIONS. NO ANOMALIES OR DEVIATIONS WERE NOTED IN THE MANUFACTURE OF THIS BATCH OF K-WIRE WHICH MAY HAVE CONTRIBUTED TO THE FAILURE OF THE K-WIRE DURING OPERATION. THUS, THE MANUFACTURE OF THE BATCH IS THEREFORE NOT LIKELY TO HAVE BEEN A CAUSE FOR THE K-WIRE FRACTURE REPORTED. THE INVESTIGATION WAS LIMITED AS THERE WAS A LACK OF CLINICAL INFORMATION, AND THE COMPLAINT DEVICE WAS DISCARDED, THUS NOT ALLOWING FOR VISUAL INSPECTION OR TESTING FOR MATERIAL ANOMALIES AND INSIGHT INTO THE MODE OF FRACTURE. THE TREND ANALYSIS SHOWS THAT THIS IS THE FIRST COMPLAINT FOR THE WIRE, AND THE FAILURE RATE IS DEEMED VERY LOW AT 0.0009%. THERE WERE NO NEW OR EMERGING RISKS IDENTIFIED AS A RESULT OF THIS COMPLAINT.

    Description of Event or Problem · 1

    DURING AN ORIF PROCEDURE FOR A LEFT PROXIMAL HUMERUS FRACTURE, AS THE SURGEON WAS USING A K-WIRE TO STABILISE THE FRACTURE, PART OF THE WIRE BROKE, LEAVING A PORTION OF IT INSIDE OF THE PATIENT'S BONE. THE SURGICAL PROCEDURE WAS SUCCESSFUL, AND NO INJURY OR COMPLICATION FOR THE PATIENT WAS REPORTED. NO ADDITIONAL CLINICAL INFORMATION WAS PROVIDED, AND THE DEVICE WAS DISCARDED. THE K-WIRE IS MANUFACTURED FROM IMPLANT-GRADE 316LVM STAINLESS STEEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082158 K-WIRE TROCAR TIP 2.0MM X 150MM ORTHOPAEDIC BONE WIRE HTY ORTHO SOLUTIONS UK LTD OS292200 1118894 05055662923124

    Patients

    Seq Age Sex Outcome Treatment
    1 Other