BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLES KIT, FOR FIBERTAK,STRAIGHT

    MDR report key: 19416678 · Received May 29, 2024

    Report

    Report Number
    1220246-2024-04221
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    December 28, 2021
    Report Date
    May 29, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    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 DEVICES DID NOT FIT WELL TOGETHER. THE DRILL BIT DID NOT GET STUCK. VISUAL EVALUATION REVEALS CIRCUMFERENTIAL ABRASION MARKS ON THE OD OF THE DRILL BIT FLUTE ON THE THE ID OF SPEAR, NEAR THE DISTAL END. THE OD OF THE DRILL BIT WAS FOUND TO MET SPECIFICATION. THE ID OF THE SPEAR COULD NOT BE CHECKED DUE TO THE DAMAGE PRESENT. A LIKELY CAUSE OF THE EVENT IS PRYING/LEVERAGING THE DEVICES DURING USE LEADING TO CONTACT BETWEEN THE DRILL AND THE SPEAR.

    Description of Event or Problem · 0

    ON 1/5/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-3600D DISPOSABLES KIT FOR FIBERTAK DRILL AND DRILL GUIDE INTERFERED WITH EACH OTHER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. SURGEON USED ANOTHER ONE TO COMPLETE CASE WITHOUT FURTHER ISSUES. ADDITIONAL INFORMATION RECEIVED 1/6/2022: THE DRILL AND DRILL GUIDE SEEM TO LOCK AND GET STUCK. THIS OCCURRED OUTSIDE OF THE PATIENTS BODY DURING A LABRUM REPAIR PROCEDURE. PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610965 DISPOSABLES KIT, FOR FIBERTAK,STRAIGHT POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. DISPOSABLES KIT, FOR FIBERTAK,STRAIGHT 12930373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown