BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET MENISCUS MENDER II DISPOSABLE

    MDR report key: 10839873 · Received November 13, 2020

    Report

    Report Number
    1219602-2020-01843
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 23, 2020
    Report Date
    December 1, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HQW
    UDI-DI
    03596010468482
    PMA / PMN Number
    K885311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). H2: ADDITIONAL INFORMATION IN H6 (HEALTH EFFECT - IMPACT CODE) AND (MEDICAL DEVICE PROBLEM CODE). H3, H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A VISUAL INSPECTION REVEALED THAT ONE MENISCAL SUTURE LOOP WAS DETACHED FROM ITS HANDLE. THERE WAS MINIMAL DEBRIS, AND THE REST OF THE SET WAS IN GOOD CONDITION. THE COMPLAINT WAS CONFIRMED, AND THE ROOT CAUSE WAS ASSOCIATED WITH DEVICE DESIGN. A CORRECTIVE ACTION FOR THIS FAILURE MODE IS IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE SCRUB NURSE HAS FOUND THAT ONCE THE MENISCAL MENDER II OPENED, ONE OF THE LOOP NEEDLE PART BROKE INTO THE TWO PARTS IMMEDIATELY: THE PROXIMAL HANDLE PART AND THE LOOP PART. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY, AND NO PATIENT INJURIES 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
    1304094 SET MENISCUS MENDER II DISPOSABLE CLIP, TANTALUM, OPHTHALMIC HQW SMITH & NEPHEW, INC. 7209485 2048092 03596010468482

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown