BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCUS STAPLE SYSTEM

    MDR report key: 10740717 · Received October 27, 2020

    Report

    Report Number
    3009540749-2020-00037
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 27, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    JDR
    PMA / PMN Number
    K151160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILLS WERE MEASURED AND WAS CONFORMING WITH PRINT SPECIFICATION. THE DEVICE HISTORY RECORD REVIEW FOUND NO RELATED NON-CONFORMANCES AND THE DOCUMENTATION SHOWS NO EVIDENCE OF ABNORMALITIES. ROOT CAUSE IS UNKNOWN. IF ADDITIONAL INFORMATION IS OBTAINED WHICH CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PROCEDURE USING THE ARCUS STAPLE SYSTEM THE DRILL BIT GOT STUCK IN THE DRILL GUIDE TWICE. THE FIRST TIME THE DRILL BIT BROKE OFF INSIDE THE GUIDE WHILE THE SURGEON WAS TRYING TO REMOVE THE STUCK DRILL BIT FROM THE GUIDE. THE SECOND TIME WITH NEW INSTRUMENTATION FROM A NEW KIT THAT WAS OPENED, A SIMILAR SITUATION OCCURRED, HOWEVER THE SECOND TIME THE SURGEON WAS ABLE TO REMOVE THE DRILL BIT AND GET THE ARCUS STAPLE IMPLANTED. NO DELAY IN SURGERY. NO IMPACT ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205397 ARCUS STAPLE SYSTEM STAPLE JDR NEXTREMITY SOLUTIONS 168528917A

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR