BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL FLEXIBLE CANNULATED 7.5MM

    MDR report key: 10112658 · Received June 2, 2020

    Report

    Report Number
    1219602-2020-00838
    Event Type
    Injury
    Date Received
    June 2, 2020
    Date of Event
    May 5, 2020
    Report Date
    July 22, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    03596010654564
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3,H6: ONE 7223163 DRILL FLEXIBLE CANNULATED 7.5MM USED FOR TREATMENT, WAS NOT RETURNED FOR EVALUATION. WITHOUT THE REPORTED PRODUCT A VISUAL OR FUNCTIONAL EVALUATION CANNOT BE PERFORMED AND THE CUSTOMERS COMPLAINT CANNOT BE CONFIRMED. THE COMPLAINT STATED: ¿DURING SURGERY, WHILE MAKING THE FEMUR TUNNEL, WHEN THE FLEXIBLE DRILL TOUCHED THE BONE IT BROKE¿. PRODUCT MANUFACTURING DOCUMENTATION SHOWS THAT THE COMPLAINT DEVICES MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER, FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: EXCESSIVE FORCE APPLIED. THE INSTRUCTION FOR USE WAS REVIEWED AND WAS FOUND TO OUTLINE PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A REVIEW OF COMPLAINTS AND MANUFACTURING BATCH RECORDS WAS PREFORMED, NO OTHER COMPLAINTS OF THIS FAILURE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, WHILE MAKING THE FEMUR TUNNEL, WHEN THE FLEXIBLE DRILL TOUCHED THE BONE IT BROKE. EVERYTHING WAS REMOVED FROM THE PATIENT USING A HEMOSTAT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. IN THE SAME BONE HOLE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572949 DRILL FLEXIBLE CANNULATED 7.5MM ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 50423016 03596010654564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention