BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL MIS INSTRUMENT SET

    MDR report key: 7984670 · Received October 19, 2018

    Report

    Report Number
    3005180920-2018-00811
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    September 19, 2018
    Report Date
    October 19, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 OCTOBER 2018. LOT 181436: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 MARCH 2018. EXPIRATION DATE: 2023-02-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM ON (B)(4) PIECES MANUFACTURER, SECOND EVENT ON THIS MAT. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D PRODUCT MANAGER ON 19 OCTOBER 2018. THE BREAKAGE OF ONE WING OF THE IMPACTOR HANDLE TIP WAS MOST LIKELY CAUSED BY A MISALIGNMENT DURING THE IMPACTION. THE HANDLE IS INTENDED TO BE IMPACTED IN ITS LONG AXIS. IMPROPER IMPACTION DIRECTION CAN OVERLOAD THE CONNECTION WITH A BENDING STRESS WITH THE CONSEQUENT RISK OF BREAKAGE OF THE HANDLE-TIP. DESPITE THIS BREAKAGE IT WAS POSSIBLE TO SUCCESSFULLY END THE SURGERY WITHOUT ANY DELAY.

    Description of Event or Problem · 1

    THE YELLOW TIP FROM THE PLASTIC IMPACTOR HANDLE BROKE DURING USE WHILE SWITCHING TIPS (USING THE INSTRUMENT WITH DIFFERENT DEVICES) DURING THE PROCEDURE. THE SURGEON WAS ABLE TO FINISH THE CASE USING THE INSTRUMENT TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823309 GENERAL MIS INSTRUMENT SET SURGICAL INSTRUMENT FOR KNEE LXH MEDACTA INTERNATIONAL SA 181436

    Patients

    Seq Age Sex Outcome Treatment
    1 Other