BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP GENERAL OFFSET-30° BROACH HANDLE - RIGHT

    MDR report key: 8439895 · Received March 21, 2019

    Report

    Report Number
    3005180920-2019-00171
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    February 19, 2019
    Report Date
    March 21, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630040742115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 MARCH 2019: LOT 1854515: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ANOTHER SIMILAR EVENT HAS BEEN REPORTED ON THIS LOT (COMPLAINT (B)(4)). VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE SPRING PLUNGER IS BROKEN. IT IS POSSIBLE THAT THIS OCCURRENCE COULD HAVE BEEN INFLUENCED BY BAD ASSEMBLY DURING PRODUCTION, HOWEVER THIS CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    DURING THE SURGERY THE BROACH HANDLE BALL SPRING FELL OUT OF ITS SIEGE. IT DID NOT FALL IN THE PATIENT. THE SURGEON USED THE STRAIGHT BROACH HANDLE TO COMPLETE THE SURGERY SUCCESSFULLY, NO CRITICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234740 HIP GENERAL OFFSET-30° BROACH HANDLE - RIGHT SURGICAL INSTRUMENT FOR HIP SURGERY LXH MEDACTA INTERNATIONAL SA 1854515 07630040742115

    Patients

    Seq Age Sex Outcome Treatment
    1 Other