BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM Q-FIX ALL SUTURE ANCHOR

    MDR report key: 21872622 · Received April 21, 2025

    Report

    Report Number
    3006524618-2025-00189
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    March 26, 2025
    Report Date
    May 15, 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

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

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4) B5 AND H6 UPDATED.

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION REVEALED THE DEVICE WAS NOT RETURNED IN ORIGINAL PACKAGING. THE ANCHOR IS PARTIALLY DEPLOYED FROM THE INSERTION TUBE. THE SUTURES STILL RUN THROUGH THE CANNULA TO THE CLEAT. THE SUTURES HAVE NO DEFECT. THE CLEAT IS FULLY EXTENDED. BIO DEBRIS IS PRESENT. A FUNCTIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE AND FOUND THE DRIVER CAN NO LONGER BE USED TO ADVANCE THE ANCHOR AS THE SPOOL CLEAT IS FULLY EXTENDED FROM THE BODY OF THE HANDLE. THE RATCHET HANDLE IS BROKEN AND WILL NO LONGER LOCK. BASED ON THE CONDITION OF THE PRODUCT MATERIAL FOUND DURING VISUAL INSPECTION, ADDITIONAL MATERIAL TESTING IS NOT REQUIRED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION 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 REVIEW OF THE SUTURE MATERIAL SPECIFICATION, FOUND THE SUTURE DIAMETER AND KNOT PULL SUTURE STRENGTH ARE SPECIFIED AND A CERTIFICATE OF ANALYSIS IS REQUIRED WITH EACH SHIPMENT. 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. OTHER FACTORS, THAT CAN CONTRIBUTE TO THE COMPLAINT EVENT, INCLUDE AN APPLICATION OF UNINTENDED INAPPROPRIATE OR EXCESSIVE FORCE TO THE DEVICE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING SURGERY, THE FIRST 2.8 MM Q-FIX ANCHOR WAS NORMAL, BUT WHEN THE HANDLE OF THE SECOND ANCHOR WAS PULLED OUT AFTER TURNING THE KNOT AT THE BACK OF IT, THE ANCHORS CAME OUT DIRECTLY, AND IT WAS NOT DEPLOYED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING SURGERY, THE FIRST 2.8 MM Q-FIX ANCHOR WAS NORMAL, BUT WHEN THE HANDLE OF THE SECOND ANCHOR WAS PULLED OUT AFTER TURNING THE KNOT AT THE BACK OF IT, THE ANCHORS CAME OUT DIRECTLY, AND IT WAS NOT DEPLOYED. ADDITIONALLY, WHEN THE SURGEON PULLED OUT THE SUTURE, IT BROKE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338875 2.8MM Q-FIX ALL SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHROCARE CORPORATION 2151810 00885556724644

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male