BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROPIERCE INSTRUMENT CURVED LEFT

    MDR report key: 10483381 · Received September 2, 2020

    Report

    Report Number
    1219602-2020-01348
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 8, 2020
    Report Date
    October 22, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    03596010605610
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 72201186 ARTHROPIERCE INSTRUMENT CURVED LEFT WAS RETURNED FOR EVALUATION. THE INFORMATION PROVIDED STATES: ¿DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE ARTHRO-PIERCE INSTRUMENT CURVED LEFT BROKE¿. VISUAL ASSESSMENT CONFIRMS COMPLAINT. THE TIP OF THE ARTHROPIERCE SHOWED BREAKGE. THERE WAS A RELATIONSHIP BETWEEN THE REPORTED EVEN AND THE DEVICE. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: EXCESSIVE FORCE OR IMPROPER CLEANING OF DEVICE. IFU (1060355) 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¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE ARTHRO-PIERCE INSTRUMENT CURVED LEFT BROKE. HOWEVER, THERE WAS NO BREAKAGE INSIDE THE PATIENT. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. HOWEVER, NO DELAY AND NO PATIENT 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
    945738 ARTHROPIERCE INSTRUMENT CURVED LEFT ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 72201186 50807924 03596010605610

    Patients

    Seq Age Sex Outcome Treatment
    1