BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM DRILL

    MDR report key: 18694229 · Received February 13, 2024

    Report

    Report Number
    1220246-2024-00926
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 26, 2024
    Report Date
    July 9, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION CONFIRMED. ONE UNPACKAGED AR-9620-10D BATCH NUMBER 95672227 WAS RECEIVED FOR EVALUATION. THE DEVICE ARRIVED ATTACHED TO THE AR-9617 BATCH 022239. THE VISUAL EVALUATION FOUND THE DEVICES BEING COLD-WELDED TOGETHER. THE DAMAGE TO THE DEVICE INSIDE THE CONNECTOR COULD NOT BE MEASURED OR EVALUATED. THE OUTSIDE DIAMETER WAS MEASURED BY DRAWING C13825 AT REVISION 4. DIAMETER (Ø .385 ± .005). THE RESULT INDICATED THAT THE DIAMETER IS IN TOLERANCE MEASURING (Ø.386). NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE DEVICES BEING COLD-WELDED TOGETHER. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND DAMAGE DUE TO REPEATED USE AND/OR REPROCESSING.

    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.

    Description of Event or Problem · 0

    ON 01/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9620-10D 10 MM DRILL BECAME STUCK WITH THE AR-9617 QUICK CONNECT DRIVE SHAFT. THIS OCCURRED DURING A CASE WHERE THE ISSUE DID NOT NEED TO BE RESOLVED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277918 10MM DRILL POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. 10MM DRILL 95672227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown