BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTPASS SCORPION, SL-MF

    MDR report key: 19422871 · Received May 30, 2024

    Report

    Report Number
    1220246-2024-04333
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 24, 2021
    Report Date
    May 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. COMPLAINT CONFIRMED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE BEING USED DURING FIRING OF THE NEEDLE AND/OR UNSECURE GRASP OF TISSUE. THE MATING PART (NEEDLE) WAS NOT RETURNED. USED AN AR-13995N/LOT# 111458823 NEEDLE DURING EVALUATION. FUNCTION TEST COULD NOT BE PERFORMED DUE TO THE RELATED CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCORPION TOP JAW DOES NOT CLOSE COMPLETELY. PER THE REP, DURING A RCR CASE, THE JAW DISLOCATED WHEN PASSING SUTURES. THERE WAS NO PATIENT INJURY AND ANOTHER SCORPION WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276707 FASTPASS SCORPION, SL-MF ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. FASTPASS SCORPION, SL-MF 13117278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown