BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOS SMALL 2.5MM DRILL W/AO QC LONG

    MDR report key: 10041698 · Received May 10, 2020

    Report

    Report Number
    1020279-2020-01538
    Event Type
    Injury
    Date Received
    May 10, 2020
    Date of Event
    April 15, 2020
    Report Date
    August 3, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION BUT THE PICTURES WERE REVIEWED, AND THE BREAKAGE WAS CONFIRMED. THE CLINICAL / MEDICAL INVESTIGATION CONCLUDED THAT, THE FLUOROSCOPIC IMAGES PROVIDED DO NOT MAKE A CLEAR VIEW OF THE BROKEN DRILL BIT OR A BROKEN PIECE TO ASSESS IF FOREIGN BODY WAS LEFT BEHIND. BASED ON THE LIMITED INFORMATION PROVIDED THE ROOT CAUSE OF THE REPORTED BREAKAGE CANNOT BE DETERMINED AND IT WAS NOT CLEAR IF A PIECE OF THE DRILL BIT WAS LEFT WITHIN THE PATIENT. THE MATERIAL COMPOSITION OF THE RETAINED DRILL BIT WHICH WAS COMPRISED OF MARTENSITIC STAINLESS STEEL, 440A, WHICH IS NOTED IN THE ASTM F 988-2002 AS AN ALLOY THAT IS UTILIZED IN MEDICAL DEVICES. THE 440A DRILL BITS ARE MANUFACTURED AND INTENDED AS EXTERNALLY COMMUNICATING DEVICES AND ARE NOT APPROVED FOR IMPLANTATION. THEREFORE, LONG TERM IMPLANTATION DATA IS NOT AVAILABLE. THE IMPACT TO THE PATIENT BEYOND POSSIBLE LOCAL IRRITATION AND/OR DISCOMFORT, MICROMOTION/OR MIGRATION, AND ADDITIONAL RADIOLOGICAL IMAGING/EXPOSURE CANNOT DETERMINED. NO FURTHER MEDICAL ASSESSMENT CAN BE RENDERED AT THIS TIME. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES FOR THE LISTED BATCH; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. DAMAGE FROM MISUSE OR ROUGH HANDLING ARE LIKELY PROBABLE CAUSES OF THE REPORTED EVENT. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY TWO DRILL BITS BROKEN WHILE DOING 3.5MM CTX SCREW FOR MEDIAL MALLEOLUS. THEY ALWAYS SEEM TO BREAK AT THAT EXACT POINT, ABOUT 1CM FROM THE PROXIMAL ASPECT OF THE FLUTES. SURGEON FELT HE WAS ON BONE WHOLE TIME, DID NOT HIT SCREW TRAFFIC. SHORT DRILL BIT WAS USED ON POSTERIOR PLATE. NO DELAY REPORTED. A S&N BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505208 EVOS SMALL 2.5MM DRILL W/AO QC LONG INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE SMITH & NEPHEW, INC. 19JUQ0012C

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R