BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE DRILL

    MDR report key: 10827776 · Received November 12, 2020

    Report

    Report Number
    3010470577-2020-02331
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    February 13, 2020
    Report Date
    August 6, 2020
    Manufacturer
    IN2BONES SAS
    Product Code
    HTW
    PMA / PMN Number
    K131920
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE I.B.S COMPRESSION AND NEUTRALIZATION OSTEOSYNTHESIS SCREWS ARE INTENDED FOR: THE FIXATION OF ARTHRODESIS, OSTEOTOMIES OR FRACTURES OF LONG OR SHORT BONES OF THE UPPER AND LOWER LIMBS; OSTEOSYNTHESIS REQUIRING A MONO OR BICORTICAL COMPRESSION. THE IMPLANTATION OF 4.5MM DIAMETER SCREWS IS TO BE PREPARED THANKS TO A G01 00091 DRILL (ASSOCIATED TO A 1.6MM K-WIRE). EVENT DESCRIPTION: DURING AN OSTEOSYNTHESIS / RECONSTRUCTION SURGERY, IT WAS REPORTED THAT WHEN THE SURGEON TRIED TO PREPARE THE SCREW PATHWAY, THE DRILL TWISTED. THE SURGEON HAD TO MAKE STRENGTH TO REMOVE THE INSTRUMENT. THE SURGERY ENDED SUCCESSFULLY WITHOUT ANY CONSEQUENCES FOR THE PATIENT. THIS EVENT IS REPORTABLE SINCE IF IT WERE TO HAPPEN AGAIN, IT COULD CAUSE A SERIOUS INJURY TO THE PATIENT. ADDITIONAL INFORMATION: THE RETURN OF THE INVOLVED INSTRUMENTS AT IN2BONES HAS BEEN REQUESTED FOR FURTHER ANALYSIS, BUT HAVE NOT YET BEEN DONE (IN2BONES INTERNAL AND DISTRIBUTOR ORGANIZATION DIFFICULTIES DURING THE COVID-19 CRISIS). HOWEVER, A PICTURE OF THE DAMAGED INSTRUMENTS HAS BEEN RECEIVED: A K-WIRE APPEARS TO BE STUCK INSIDE THE DRILL, AND BOTH INSTRUMENTS ARE TWISTED NEAR THEIR DISTAL EXTREMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292612 REUSABLE DRILL DRILL DIAM 3.0 - A.O - LG 110MM, NON STERILE CANNULATED 1.6MM HTW IN2BONES SAS G01 00091 1502050

    Patients

    Seq Age Sex Outcome Treatment
    1