BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP GENERAL OFFSET-30° BROACH HANDLE - RIGHT

    MDR report key: 8619673 · Received May 17, 2019

    Report

    Report Number
    3005180920-2019-00388
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 17, 2019
    Report Date
    May 17, 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 14 MAY 2019: LOT 1854515: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, TWO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THIS SAME LOT ((B)(4)). VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE SPRING BALL PLUNGER IS CAME APART. IT IS POSSIBLE THIS OCCURRENCE WAS INFLUENCED BY VARIATION IN PRODUCTION/ASSEMBLY HOWEVER THIS CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    DURING A SURGERY THE LOCKING BALL OF THE INSTRUMENT FELL OUT OF THE HANDLE. THE BALL DID NOT FALL IN THE PATIENT. THE STRAIGHT AMIS-BROACH HANDLE HAS BEEN USED TO COMPLETE THE SURGERY SUCCESSFULLY, NO CRITICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415258 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