BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUFEX DIRECTOR MRR ANGLED BULLET

    MDR report key: 19988555 · Received August 14, 2024

    Report

    Report Number
    1219602-2024-01744
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 20, 2024
    Report Date
    September 23, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    00885556533314
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    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. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO 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 EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ACUFEX DIRECTOR ROOT REPAIR BULLET DID NOT WORK, THE CANNULA OF THE MENISCAL ROOT KIT DID NOT PASS THROUGH THE BULLET. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895003 ACUFEX DIRECTOR MRR ANGLED BULLET ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. UKNOWN 00885556533314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female