BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP GENERAL OFFSET-30° BROACH HANDLE - RIGHT

    MDR report key: 8830086 · Received July 26, 2019

    Report

    Report Number
    3005180920-2019-00612
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    June 26, 2019
    Report Date
    July 26, 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 09 JULY 2019: LOT 1854515: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THREE OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THIS SAME LOT. VISUAL INSPECTION PERFORMED BY R&D HIP PROJECT MANAGER: THE SPRING BALL PLUNGER IS CAME APART AS DESCRIBED IN THE COMPLAINT. IT IS POSSIBLE THIS OCCURRENCE WAS INFLUENCED BY VARIATION IN PRODUCTION/ASSEMBLY HOWEVER THIS CANNOT BE CONFIRMED. EVALUATION OF THE SOLUTION ON GOING.

    Description of Event or Problem · 1

    DURING SURGERY THE LOCKING BALL FELL OUT OF THE HANDLE. THE BALL IS NOT FALLING IN THE PATIENT. THE SURGERY HAS BEEN COMPLETED USING ANOTHER INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623984 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