BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOS SMALL 2.5MM DRILL W/AO QC LONG

    MDR report key: 10453548 · Received August 26, 2020

    Report

    Report Number
    1020279-2020-04217
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    August 7, 2020
    Report Date
    August 6, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWE
    UDI-DI
    00885556635766
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 IMAGE PROVIDED CONFIRMED THE REPORTED BROKEN DRILL BIT AND THAT IT WAS EXTRUDING BEYOND THE BONE ON THE OPPOSITE SIDE. BASED ON THE LIMITED INFORMATION PROVIDED THE ROOT CAUSE OF THE REPORTED BREAKAGE CANNOT BE DETERMINED. THE MATERIAL COMPOSITION OF THE POSSIBLE RETAINED DRILL IS 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 DRILLS ARE MANUFACTURED AND INTENDED AS EXTERNALLY COMMUNICATING DEVICES AND ARE NOT APPROVED FOR IMPLANTATION. THEREFORE, LONG TERM IMPLANTATION DATA IS NOT AVAILABLE. IF RETAINED, THE IMPACT TO THE PATIENT BEYOND THE LIKELY 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 REVIEW OF THE COMPLAINT HISTORY DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCH. 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 A BIG TIBIAL PLATEAU SURGERY, THE EVOS SMALL 2.5MM DRILL W/AO QC LONG BROKE, INTERNAL TO PATIENT. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES. THE PATIENT WAS NOT INJURED BEYOND THE DESCRIBED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920896 EVOS SMALL 2.5MM DRILL W/AO QC LONG INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE SMITH & NEPHEW, INC. 71175022 20BUQ0027 00885556635766

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention