BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCUS STAPLE SYSTEM

    MDR report key: 10573837 · Received September 23, 2020

    Report

    Report Number
    3009540749-2020-00032
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    August 18, 2020
    Report Date
    September 23, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    JDR
    PMA / PMN Number
    K151160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL AND GUIDE BUSHING WERE COMPARED WITH PRINT SPECIFICATIONS AND FOUND TO BE CONFORMING. DEVICE HISTORY RECORDS RELATED TO THE EVENT WERE REVIEWED. THERE WERE NO NON-CONFORMANCE'S DETECTED THROUGH THE DEVICE HISTORY RECORD REVIEW. A SUPPLEMENTAL REPORT WILL BE FILED IF NEW INFORMATION IS OBTAINED WHICH CHANGES THE INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY WITH THE ARCUS STAPLE SYSTEM, THE DRILL WAS STUCK IN THE GUIDE AND THE GUIDE PROCEEDED TO WHIP AROUND THE DRILL. THE SURGEON GRABBED A HOLD OF THE GUIDE TO STABILIZE IT, AND REMOVED THE DRILL FROM THE GUIDE. SURGEON MANUALLY MARKED WHERE TO DRILL ON THE PATIENTS BONE AND DRILL WAS USED WITHOUT THE GUIDE TO COMPLETE THE SURGERY. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037633 ARCUS STAPLE SYSTEM STAPLE JDR NEXTREMITY SOLUTIONS ARC-1008K 168525817D

    Patients

    Seq Age Sex Outcome Treatment
    1