BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSURE

    MDR report key: 3140912 · Received June 3, 2013

    Report

    Report Number
    1219602-2013-00119
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS REPORTED TO THE MANUFACTURER ON (B)(4) 2013 AT THAT TIME THE MANUFACTURER MADE AN INITIAL ASSESSMENT PER 21 CFR 803, THE MDR REGULATION AND DETERMINED THAT THE COMPLAINT WAS NOT REPORTABLE. UPON EVALUATION OF THE RETURNED DEVICE, THE MANUFACTURER HAS RE-ASSESSED THE COMPLAINT AND IS FILING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803. DEVICE EVALUATION: VISUAL INSPECTION OF THE RETURNED SCREW CONFIRMED THAT THERE WAS DAMAGE TO THE DISTAL TIP OF THE SCREW BETWEEN THE 3RD AND THE 5TH THREAD OF THE SCREW, WHICH INDICATED THAT THE SMALLER DISTAL OF THE SCREW WAS INSERTED WITHOUT ANY PROBLEM, BUT ONCE THE WIDER THREADS STARTED TO BEING INSERTED IT GOT DAMAGED AND 3 OF THE THREADS BROKE OFF. PER THE INSTRUCTIONS FOR USE, "PREPARE THE TIBIAL AND FEMORAL TUNNELS IN ACCORDANCE WITH THE ACCEPTED SURGICAL TECHNIQUE. IT IS THE SURGEON RESPONSIBILITY TO CHOOSE AN APPROPRIATE SIZE BIOSURE HA INTERFERENCE SCREW BASED ON THE PATIENT BONE QUALITY. IN CASES WHERE HARD BONE IS ENCOUNTERED, IT IS RECOMMENDED THAT A TAP 1 MM LARGER THAN THE SCREW SIZE BE USED". (B)(4).

    Description of Event or Problem · 1

    BROKEN SCREW DURING AN ACL REPAIR, THE SURGEON WAS USING BIOSURE HA, 9MM X 30MM SCREW TO ACHIEVE TIBIAL FIXATION, WITH A SIZE 8 HAMSTRING GRAFT. UPON INSERTING THE SCREW, THE TIP BROKE AND REPORTEDLY SEPARATED FROM THE SCREW ITSELF. THE SCREW WAS REMOVED AND THE PROCEDURE WAS ULTIMATELY COMPLETED USING A BIOSURE HA 9MM X 25MM SCREW. NO PATIENT INJURIES OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244329 BIOSURE BIOSURE HA, 9MM X 30MM HWC MANSFIELD MANUFACTURING SITE 50440890

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR