BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM Q-FIX ALL SUTURE ANCHOR

    MDR report key: 21229430 · Received January 24, 2025

    Report

    Report Number
    3006524618-2025-00022
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    January 3, 2025
    Report Date
    March 3, 2025
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    UDI-DI
    00885556724644
    PMA / PMN Number
    K133727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE CASE-(B)(4). H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL EVALUATION SHOWED THE DEVICE WAS NOT RETURNED IN ORIGINAL PACKAGING. THE ANCHOR IS STILL IN THE INSERTION TUBE. THE INSERTION TUBE IS BENT AT THE PROXIMAL END. BIO DEBRIS IS INSIDE THE TUBE AND ON THE ANCHOR. THE SUTURES STILL RUN THROUGH THE CANNULA TO THE CLEAT. THE CLEAT IS FULLY EXTENDED AND LOCKED. A FUNCTIONAL EVALUATION SHOWED THE DRIVER CAN NO LONGER BE USED TO ADVANCE THE ANCHOR. THE RATCHET WILL NOT LOCK AND CAN FULLY EXTEND THE CLEAT DOWN AND BACK UP WITHOUT MOVING THE ANCHOR. 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. A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE FAILURE INCLUDE PROCEDURAL VARIANCE, OR DEVIATIONS FROM ESTABLISHED PROTOCOLS, INCREASING RISKS AND LEADING TO UNINTENDED CONSEQUENCES ((1)INCORRECT BONE HOLE PREPARATION. (2) IMPROPER DEPTH INSERTION.). BASED ON THIS INVESTIGATION, THERE IS NO EVIDENCE TO SUGGEST A DESIGN, MATERIAL OR MANUFACTURING ISSUE. THEREFORE, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE A SHOULDER ARTHROSCOPY, THE Q-FIX ANCHOR COULDN'T BE DEPLOYED AFTER DRILLING A HOLE BY APPROPRIATIVE TOOLS AND INSERTING THE Q-FIX ANCHOR CAUSING A FAILURE IN THE SUTURING PROCESS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE DRILLING AN ADDITIONAL BONE HOLE AND SUING A Q FIX 2.8MM TO PREPARE THE INSERTION SITE. A VOID WAS LEFT IN PATIENT. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721704 2.8MM Q-FIX ALL SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHROCARE CORPORATION 2120555 00885556724644

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female