BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DRILL

    MDR report key: 10907385 · Received November 26, 2020

    Report

    Report Number
    1625507-2020-00222
    Event Type
    Injury
    Date Received
    November 26, 2020
    Date of Event
    October 25, 2020
    Report Date
    November 25, 2020
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBF
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN. NO EVALUATION WAS PERFORMED, AS THE PERFORATOR BIT WAS DISCARDED AND THE MOTOR WAS NOT RETURNED. IF THE MOTOR IS RETURNED IN THE FUTURE, PRODUCT ANALYSIS MAY BE PERFORMED. THE DEVICE USER MANUAL WARNINGS SECTION INCLUDES INSTRUCTIONS TO CHECK THE DEVICE FOR DAMAGE BEFORE USE. IF DAMAGE IS FOUND, THE DEVICE SHOULD NOT BE USED. WE WILL CONTINUE TO TRACK AND TREND THIS COMPLAINT TYPE. PMA / 510(K) #: NO INFORMATION AVAILABLE ON DEVICE TO CONFIRM APPLICABLE 510(K). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIOTOMY WHILE DRILLING BUR HOLES, IT APPEARS WHEN THE PERFORATOR BIT REACHED THE APPROPRIATE DEPTH IN THE BONE, THE CLUTCH MECHANISM DID NOT STOP AND CAUSED THE MOTOR TO SPIN IN THE SURGEON'S HAND. ON FOLLOW-UP, IT WAS REPORTED THAT AN INJURY/SPRAIN ON THE SURGEON'S WRIST WAS EXPERIENCED AND THAT A SPECIALIST MAY BE SEEN IF THE PAIN PERSISTS. ON FURTHER FOLLOW-UP, IT WAS REPORTED THAT THE MOTOR WILL NOT BE RETURNED AND THE PERFORATOR BIT WAS DISCARDED. NO INFORMATION WAS AVAILABLE ON THE MODEL OR SERIAL NUMBER OF THE MOTOR DRILL OR PERFORATOR BIT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374713 UNKNOWN DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) HBF MDT POWERED SURGICAL SOLUTIONS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other