BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTPASS SCORPION, SL-MF

    MDR report key: 19541599 · Received June 14, 2024

    Report

    Report Number
    1220246-2024-05832
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    February 22, 2021
    Report Date
    June 14, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867090590
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. THE PRECISE CAUSE FOR NEEDLES NOT RETRACTING EASILY DURING EVALUATION. THE MATING PART (NEEDLE) WAS NOT RETURNED. USED AN AR-13995N/LOT# 111458823 NEEDLE DURING EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND TEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A SHOULDER ARTHROSCOPY PROCEDURE THE NEEDLE WOULD NOT ADVANCE AND BECAME JAMMED INSIDE THE INSTRUMENT. IT WAS REPLACED WITH ANOTHER HAND INSTRUMENT AND THE CASE WAS CONTINUED. IN ADDITION THE SHAVER STARTED WORKING INTERMITTENTLY WHILE IN USE. IT WAS ALSO REPLACED AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939377 FASTPASS SCORPION, SL-MF ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. FASTPASS SCORPION, SL-MF 86760C 00888867090590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown