BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM DRILL W/QC

    MDR report key: 8448489 · Received March 25, 2019

    Report

    Report Number
    1020279-2019-01156
    Event Type
    Injury
    Date Received
    March 25, 2019
    Date of Event
    February 28, 2019
    Report Date
    September 4, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    UDI-DI
    03596010519696
    PMA / PMN Number
    K123055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NEW ADDITIONAL INFORMATION THAT WAS RECEIVED FOR THIS CASE.

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICE WAS NOT RETURNED. THE MEDICAL EVALUATION CONCLUDED THAT, WITHOUT THE PRODUCT RETURN FOR EVALUATION, THE ROOT CAUSE OF THE REPORTED DRILL TIP BREAKAGE CANNOT BE CONCLUDED. THE MATERIAL COMPOSITION OF THE RETAINED DRILL TIP IS REPORTED AS A MARTENSITIC STAINLESS STEEL, 440A, WHICH IS NOTED IN THE ASTM F 988-2002 AS AN ALLOY THAT IS UTILIZED IN MEDICAL DEVICES. THIS ALLOY IS NEITHER BIO-INERT NOR APPROVED FOR IMPLANTATION. HOWEVER, ACCORDING TO THE SURGEON, IT COULD CAUSE MORE DAMAGE TO RETRIEVE THE BROKEN PIECE THAN TO LEAVE IT INSIDE THE PATIENT. IN ADDITION, MICRO-MOTION AND/OR MIGRATION OF THE RETAINED FRAGMENTS IS UNLIKELY SINCE THE TIP IN IN THE HUMERAL CANAL. PER REPORT, THE PATIENT IS DOING GREAT. THEREFORE, NO FURTHER CLINICAL MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. WITHOUT THE ACTUAL DEVICE INVOLVED AND/OR DEVICE INFORMATION, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THE COMPLAINT CAN BE RE-OPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE TIP OF THE DRILL BROKE AND WAS LEFT IN THE PATIENT IN THE HUMERAL CANAL DUE TO THE SURGEON DECIDED THAT IT COULD CAUSE MORE DAMAGE TO RETRIEVE THE BROKEN PIECE THAN LEFT IT INSIDE THE PATIENT. THE SURGERY CONTINUED WITHOUT DELAY WITH A REPLACEMENT S&N DRILL BIT AND THE FINAL OUTCOME OF THE PATIENT WAS GREAT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE TIP OF THE DRILL BROKE AND WAS LEFT IN THE PATIENT IN THE HUMERAL CANAL. THE SURGERY CONTINUED WITHOUT DELAY WITH A REPLACEMENT DRILL BIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243479 2.0MM DRILL W/QC PLATE, FIXATION, BONE HRS SMITH & NEPHEW, INC. 03596010519696

    Patients

    Seq Age Sex Outcome Treatment
    1 Other