BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TFCC MENDER DISPOSABLE SUTURE SYSTEM

    MDR report key: 10378390 · Received August 7, 2020

    Report

    Report Number
    1219602-2020-01195
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    July 7, 2020
    Report Date
    September 2, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWQ
    UDI-DI
    03596010563279
    PMA / PMN Number
    K885311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED 7210752 TFCC MENDER DISPOSABLE SUTURE SYSTEM, INTENDED FOR USE IN TREATMENT, HAS NOT RETURNED FOR EVALUATION. WITHOUT THE REPORTED PRODUCT A VISUAL AND FUNCTIONAL EVALUATION CANNOT BE PERFORMED AND THE CUSTOMER¿S COMPLAINT CANNOT BE CONFIRMED. FROM THE INFORMATION PROVIDED, ¿DURING AN ANTERIOR HORN MENISCAL REPAIR, THE NEEDLE OF THE MENDER SUTURE SYSTEMS KEPT BENDING UPON ENTRY INTO THE PATIENT'S JOINT, THIS WOULD NOT ALLOW THE SUTURE TO BE SHUTTLED THROUGH¿. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER, FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: EXCESSIVE FORCE APPLIED DURING USE. THE INSTRUCTION FOR USE OUTLINES PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A REVIEW OF THE COMPLAINT AND MANUFACTURING RECORDS WAS PERFORMED AND INDICATED SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR HORN MENISCAL REPAIR, THE NEEDLE OF THE MENDER SUTURE SYSTEMS KEPT BENDING UPON ENTRY INTO THE PATIENT'S JOINT, THIS WOULD NOT ALLOW THE SUTURE TO BE SHUTTLED THROUGH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. 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
    842256 TFCC MENDER DISPOSABLE SUTURE SYSTEM PASSER HWQ SMITH & NEPHEW, INC. 7210752 2034283 03596010563279

    Patients

    Seq Age Sex Outcome Treatment
    1