BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSURE RATCHET DRIVER

    MDR report key: 10428786 · Received August 19, 2020

    Report

    Report Number
    1219602-2020-01286
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    July 28, 2020
    Report Date
    October 1, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    03596010615442
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3, H6: ONE 72201888 BIOSURE RATCHET DRIVER, HAS NOT RETUNED FOR EVALUATION. WITHOUT THE REPORTED PRODUCT, A VISUAL OR FUNCTIONAL EVALUATION CANNOT BE PERFORMED AND THE CUSTOMERS COMPLAINT CANNOT BE CONFIRMED. THE INFORMATION PROVIDED STATES: ¿DURING LCP, LCA AND LCM ARTHROSCOPY PROCEDURE, THE BIOSURE RATCHET DRIVER BROKE IN THE DOCTOR'S HANDS¿. THIS IS A FOUR-YEAR-OLD DEVICE. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE WITHOUT THE PERTINENT CLINICAL DETAILS; HOWEVER, FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE IMPROPER CLEANING OF DEVICE. THE INSTRUCTION FOR USE STATES: ¿PAY CAREFUL ATTENTION TO CLEANING DEVICES WITH CHALLENGING DESIGN FEATURES. CHALLENGING DESIGN FEATURES CAN INCLUDE, BUT NOT LIMITED TO, SUCTION LEVERS, STOPCOCKS, INTERFACES, CANNULATIONS, HOLES, BLIND HOLES, CREVICES, HINGES, MATING SURFACES, ETC¿. COMPLAINT HISTORY REVIEW INDICATED NO SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED. BATCH REVIEW INDICATED NO CONDITION, PRODUCT OR PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LCP, LCA AND LCM ARTHROSCOPY PROCEDURE, THE BIOSURE RATCHET DRIVER BROKE IN THE DOCTOR'S HANDS. THE INSTRUMENT WAS INSIDE THE PATIENT. NO DELAY AND THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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
    888283 BIOSURE RATCHET DRIVER ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 72201888 50614615 03596010615442

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R