BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROWN DRILL T2 ICF

    MDR report key: 10576685 · Received September 23, 2020

    Report

    Report Number
    0009610622-2020-00539
    Event Type
    Injury
    Date Received
    September 23, 2020
    Date of Event
    August 26, 2020
    Report Date
    September 23, 2020
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HWE
    UDI-DI
    07613327346473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SURGEON TREATED A CHRONIC CHARCOT FOOT IN A MEDIAL COLUMN PROCEDURE AND PROVIDED THE FOLLOWING FEEDBACK: ¿CROWN DRILL AND BONE PLUG SEEMED INTUITIVE BUT IT WAS A LITTLE STRUGGLE.¿ ADDITIONAL INFO RECEIVED: "THE STRUGGLE WITH THE CROWN DRILL / BONE PLUG EXTRACTOR WAS IT WAS TOO BIG FOR THE PATIENT AND FRACTURED THE PROXIMAL PORTION OF THE 1ST MET HEAD. IT DID NOT ALTER THE OUTCOME OF THE CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039158 CROWN DRILL T2 ICF INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER TRAUMA KIEL 2358-3105 UNKNOWN 07613327346473

    Patients

    Seq Age Sex Outcome Treatment
    1 Other