BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEP DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK

    MDR report key: 18838913 · Received March 5, 2024

    Report

    Report Number
    1220246-2024-01302
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 13, 2024
    Report Date
    August 29, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867006287
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE STEP DRILL FOR 3.0MM BIO-SUTURETAK® WAS RETURNED STUCK INSIDE AR-1946. THE DRILL WAS OBSERVED WITH RUST SPOTS AROUND THE EDGES OF THE FLAT AREAS OF THE DRILL. FUNCTIONAL TESTING PERFORMED CONFIRM THAT THE STEP DRILL WAS NOT ABLE TO MOVE FROM THE INNER DIAMETER OF THE SPEAR, FOR 2.8 MM FASTAK¿ II, 3.0 MM SUTURETAK®, TROCAR AND 2.9 MM PUSHL OCK®, TROCAR TIP WITH CIRCUMFERENTIAL TEETH. THE MOST LIKELY CAUSE OF THIS FAILURE IS ATTRIBUTED TO WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE OF THE AR-1946 THAT WAS MANUFACTURED IN 2014.

    Description of Event or Problem · 0

    ON 02/19/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1250LT STEP DRILL GOT STUCK IN THE DRILL GUIDE WHEN MAKING THE PRE-HOLE. THIS OCCURRED DURING A CASE WHERE ANOTHER AR-1250LT WAS USED TO COMPLETE THE CASE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882294 STEP DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK DRILL BIT HWE ARTHREX, INC. STEP DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK UNK 00888867006287

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown