BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOS SMALL 2.5MM DRILL W/AO QC LONG

    MDR report key: 8512572 · Received April 14, 2019

    Report

    Report Number
    1020279-2019-01538
    Event Type
    Injury
    Date Received
    April 14, 2019
    Date of Event
    March 22, 2019
    Report Date
    October 20, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWE
    UDI-DI
    00885556635766
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICE WAS NOT RETURNED. WITHOUT THE ACTUAL PRODUCT INVOLVED AND/OR DEVICE INFORMATION, OUR INVESTIGATION CANNOT PROCEED. THE MEDICAL INVESTIGATION CONCLUDED THAT, WITHOUT THE PRODUCT RETURN FOR EVALUATION, THE ROOT CAUSE OF THE REPORTED EVOS DRILL BIT BREAKAGE CANNOT BE CONCLUDED. THE MATERIAL COMPOSITION OF THE RETAINED DRILL BIT TIP ,WHICH WAS ¿NOT REMOVED¿, IS COMPRISED OF MARTENSITIC STAINLESS STEEL 440A AND IS NOTED IN THE ASTM F 988-2002 AS AN ALLOY THAT IS UTILIZED IN MEDICAL DEVICES. HOWEVER, THE 440A DRILL BIT TIPS ARE MANUFACTURED AND INTENDED AS EXTERNALLY COMMUNICATING DEVICES AND ARE NOT APPROVED FOR IMPLANTATION. THEREFORE, LONG-TERM IMPLANTATION DATA IS NOT AVAILABLE, AS IT IS NOT SPECIFIED AS AN IMPLANTABLE ALLOY. IT REMAINS UNKNOWN IF CORROSION, MICRO-MOTION AND/OR MIGRATION OF THE RETAINED FRAGMENTS ARE LIKELY. THE IMPACT TO THE PATIENT OF THE RETAINED NON-IMPLANTABLE FRAGMENT OF THE EXTERNALLY COMMUNICATING DEVICE, SUCH AS POSSIBLE LOCAL IRRITATION AND/OR DISCOMFORT, AND ADDITIONAL RADIOLOGICAL IMAGING/EXPOSURE CANNOT BE COMPLETELY RULED OUT. NO FURTHER MEDICAL ASSESSMENT CAN BE RENDERED AT THIS TIME. 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 · 1

    IT WAS REPORTED THAT THE DRILL BIT BROKE INTRAOPERATIVELY. FRAGMENT LEFT IN PATIENT. DELAY OF LESS THAN 30MIN REPORTED. A SMITH&NEPHEW BACK UP DEVICE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305689 EVOS SMALL 2.5MM DRILL W/AO QC LONG INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE SMITH & NEPHEW, INC. 00885556635766

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R