BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0/4.0 CANNULATED DRILL BIT (210-40-001)

    MDR report key: 3138095 · Received May 30, 2013

    Report

    Report Number
    3007420745-2013-00001
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 23, 2013
    Manufacturer
    TRILLIANT SURGICAL LTD
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE INVOLVED DEVICE WAS NOT RETURNED TO THE PROPERLY EVALUATED, ONLY PROBABLE CAUSES WERE IDENTIFIED. HERE ARE PROBABLE CAUSES: DRILL BIT MAY HAVE COME IN CONTACT WITH THE K-WIRE - PHYSICIAN DENIED THAT THERE WAS BENDING. IF THIS WERE THE CASE, THE IFU ALREADY CAUTIONS USERS ABOUT BENDS AND PROVIDES METHOD TO AVOID THEM; DRILL BIT MAY HAVE COME IN CONTACT WITH DENSE OBJECT; CANNULATION OF THE DRILL MAY HAVE BEEN MISALIGNED. IF THIS WERE THE CASE, THIS DEVICE WAS PREVIOUSLY REVISED TO INCLUDE A SPECIFICATION TO CHECK CONCENTRICITY. (B)(4). ADDITIONAL PT INJURY IS UNLIKELY. WITHOUT THE DEVICE TEST, THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE.

    Description of Event or Problem · 1

    PHYSICIAN AT (B)(6) OUTPATIENT SURGERY CENTER (B)(6), WAS USING A TRILLIANT SURGICAL 3.0/4.0MM CANNULATED DRILL BIT (210-40-001) TO PERFORM A 5TH METATARSAL AVULSON REPAIR. DURING THE PROCEDURE, THE DRILL BIT SPLIT AND CONTRIBUTED TO A SMALL FRACTURE OF THE PT'S RIGHT FOOT. THE PHYSICIAN USED CRUSHED BONE GRAFT TO FILL IN THE AREA AND SECURED IT WITH A WASHER AND SCREW. TRILLIANT WAS NOTIFIED OF THE EVENT ON (B)(4) 2013. DUE TO "COMPANY POLICY", (B)(6) WOULD NOT RELEASE PRODUCT INVOLVED TO TRILLIANT FOR INSPECTION/TESTING AND ONLY PROVIDED PHOTOS OF THE DAMAGED PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238427 3.0/4.0 CANNULATED DRILL BIT (210-40-001) 3.0/4.0 DRILL BIT HWC TRILLIANT SURGICAL LTD 106149

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention