BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM Q-FIX ALL SUTURE ANCHOR

    MDR report key: 20002655 · Received August 20, 2024

    Report

    Report Number
    3006524618-2024-00321
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    July 27, 2024
    Report Date
    September 27, 2024
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    UDI-DI
    00885556724606
    PMA / PMN Number
    K133727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE:(B)(4).

    Additional Manufacturer Narrative · 0

    H10: H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IF ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT IS RECEIVED IN THE FUTURE, THIS INVESTIGATION WILL BE REOPENED FOR FURTHER ASSESSMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE 1.8 MM Q-FIX ANCHOR WAS NOT DEPLOYING. THE PROCEDURE WAS COMPLETED PLACING A S+N BACK UP DEVICE INTO THE ORIGINALLY BONE HOLE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396873 1.8MM Q-FIX ALL SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHROCARE CORPORATION 2136251 00885556724606

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown