BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP GENERAL OFFSET-30 BROACH HANDLE - LEFT

    MDR report key: 11626168 · Received April 7, 2021

    Report

    Report Number
    3005180920-2021-00269
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 9, 2021
    Report Date
    April 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630040742122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 MARCH 2021: LOT 1111998: 11 ITEMS MANUFACTURED AND RELEASED ON 02-FEB-2012. NO ANOMALIES FOUND RELATED TO THE PROBLEM. SINCE 2017 TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THIS LOT. ADDITIONAL DEVICE INVOLVED: HIP GENERAL 01.10.10.131 OFFSET-30° BROACH HANDLE - LEFT LOT. 1111157. BATCH REVIEW PERFORMED ON 18 MARCH 2021: LOT 1111157: 15 ITEMS MANUFACTURED AND RELEASED ON 12-SEPT-2011. NO ANOMALIES FOUND RELATED TO THE PROBLEM. SINCE 2017 TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THIS LOT. ADDITIONAL DEVICE INVOLVED: HIP GENERAL 01.15.10.0133 STRAIGHT AMIS BROACH HANDLE LOT. 1952432 BATCH REVIEW PERFORMED ON 18 MARCH 2021: LOT 1952432: 60 ITEMS MANUFACTURED AND RELEASED ON 03-SEPT-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ANOTHER SIMILAR EVENT HAS BEEN REPORTED ON THIS LOT.

    Description of Event or Problem · 1

    DURING THE SAME SURGERY THE BROACHES HANDLES DISASSEMBLED WHILE THE SURGEON WAS SWITCHING FROM A BROACH TO THE NEXT ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY USING EXTRA STRAIGHT BROACH HANDLES, BUT THERE WERE 40 MINUTES OF DELAY DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528965 HIP GENERAL OFFSET-30 BROACH HANDLE - LEFT SURGICAL INSTRUMENT FOR HIP SURGERY LXH MEDACTA INTERNATIONAL SA 01.10.10.131 1111998 07630040742122

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other