BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30MM TAP

    MDR report key: 11591553 · Received March 30, 2021

    Report

    Report Number
    1220246-2021-02800
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    March 9, 2021
    Report Date
    September 7, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-9621-30T, BATCH 022032 TAP WAS RECEIVED FOR INVESTIGATION. IT WAS IDENTIFIED USING MICRO-VU THAT 30.30 MM OF DIMENSION A FOR THE TAP SHAFT LENGTH REMAINED OUT OF THE LISTED 31.66 MM IN THE DESIGN DRAWING FOR COMPONENT C13793-04. BREAKAGE WAS NOTED AT THE PROXIMAL THREADING, ACCOUNTING FOR THE REDUCTION IN LENGTH OF THE SHAFT. THE FRAGMENTS GENERATED DURING THE EVENT WERE NOT RETURNED FOR INSPECTION. MATERIAL ANALYSIS TESTING IDENTIFIED THAT THE RETURNED AR-9621-30T MET ALL AS-RECEIVED SPECIFICATIONS, ADDITIONALLY. THE BONE QUALITY ENCOUNTERED DURING THE CASE WAS NOT PROVIDED. AS SUCH, THE OBSERVED CONDITION IS MOST LIKELY THE RESULT OF USER APPLIED MECHANICAL FORCES DURING INSERTION.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE AR-9621-30T TAP BROKE OFF DURING A PROCEDURE. ALL BROKEN PIECES WERE RETRIEVED AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490432 30MM TAP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. 30MM TAP 022032

    Patients

    Seq Age Sex Outcome Treatment
    1