BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET MENISCUS MENDER II DISPOSABLE

    MDR report key: 11152575 · Received January 11, 2021

    Report

    Report Number
    1219602-2021-00107
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    December 23, 2020
    Report Date
    February 16, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HQW
    UDI-DI
    03596010468482
    PMA / PMN Number
    K885311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10, H3,H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. AN ANALYSIS OF THE CUSTOMER PROVIDED IMAGES CONFIRMED THAT THE MENISCAL LOOP SUTURE DEVICES HAD DETACHED FROM THEIR HANDLES. A REVIEW OF THE DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE WAS ASSOCIATED WITH DEVICE DESIGN.

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 C.F.R. PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING SURGERY, THE "MENISCUS MENDER II (DISPOSABLE SET)" HAD QUALITY ISSUES, THE SURGICAL STAFF HAD ISSUES GETTING THE NEEDLES OUT OF THE PLASTIC FORMS THEY COME IN. A PICTURE PROVIDED SHOWS A BREAKAGE/DISASSEMBLY BETWEEN HEAD(LOOP) AND SHAFT (MENISCAL MENDER). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY SIGNIFICANT USING A BACK-UP DEVICE. NO PATIENT INJURIES OR 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
    41943 SET MENISCUS MENDER II DISPOSABLE CLIP, TANTALUM, OPHTHALMIC HQW SMITH & NEPHEW, INC. 7209485 2055698 03596010468482

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR