BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUFF STITCH 70 DEG RIGHT

    MDR report key: 10497083 · Received September 4, 2020

    Report

    Report Number
    1219602-2020-01359
    Event Type
    Injury
    Date Received
    September 4, 2020
    Date of Event
    July 8, 2020
    Report Date
    October 12, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    03596010448880
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 7209157 CUFF STITCH 70 DEG RIGHT, RETUNED FOR EVALUATION. THE INFORMATION PROVIDED STATES: ¿DURING SURGERY THE STITCH OF THE CUFF STITCH CRACKED¿. THIS IS A ONE-YEAR-OLD DEVICE. VISUAL ASSESSMENT CONFIRMS BREAKAGE. 70 DEGREE TIP HAS BEEN BROKEN OFF. 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 OR IMPROPER USE OF DEVICE. THE INSTRUCTION FOR USE (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¿. 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 RELE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE STITCH OF THE CUFF STITCH CRACKED. PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE, IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS 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
    958720 CUFF STITCH 70 DEG RIGHT ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 7209157 50823213 03596010448880

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention