BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QFIX 1.8 MINI SUTURE ANCHOR

    MDR report key: 23392435 · Received October 27, 2025

    Report

    Report Number
    3006524618-2025-00614
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 7, 2025
    Report Date
    January 30, 2026
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    UDI-DI
    00885556662618
    PMA / PMN Number
    K172165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: H2: CORRECTED DATA ON H6 (TYPE OF INVESTIGATION & INVESTIGATION FINDINGS) AND ON H11: RESULTS OF INVESTIGATION. H3, H6: PART OF THE DEVICE, USED IN TREATMENT, WAS RECEIVED FOR EVALUATION. A VISUAL EVALUATION SHOWED THE DEVICE WAS NOT RETURNED IN ORIGINAL PACKAGING. THE ANCHOR AND SUTURES WERE NOT RETURNED. THE TUBE FERRULE HAS BEEN PUSHED BACK INTO THE HANDLE BODY ALLOWING THE INSERTION TUBE TO MOVE AROUND FREELY. BIO DEBRIS IS INSIDE THE TUBE. THE CLEAT IS FULLY EXTENDED. A MATERIAL ASSESSMENT COULD NOT BE PERFORMED DUE TO THE PART NOT BEING RETURNED FOR EVALUATION. HOWEVER, AN IMAGE EVALUATION WAS PERFORMED AND FOUND A BROKEN SUTURE NEAR TO THE Q FIX DEVICE. THE SUTURE SHOWS FRAYED THREADS. 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 REVIEW OF THE MATERIAL SPECIFICATION FOUND THAT SUTURE STRENGTH REQUIREMENTS ARE SPECIFIED. A CERTIFICATE OF ANALYSIS IS REQUIRED WITH EACH SHIPMENT VERIFYING SUTURE DIAMETER & KNOT PULL SUTURE STRENGTH. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE FINDINGS CANNOT LEAD TO A CLEAR CAUSE OF THE REPORTED EVENT. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE EXCESSIVE FORCE OR CONTACT WITH A SHARP GRASPER/INSTRUMENT. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Additional Manufacturer Narrative · 0

    H11: H3, H6: PART OF THE DEVICE, USED IN TREATMENT, WAS RECEIVED FOR EVALUATION. A VISUAL EVALUATION SHOWED THE DEVICE WAS NOT RETURNED IN ORIGINAL PACKAGING. THE ANCHOR AND SUTURES WERE NOT RETURNED. THE TUBE FERRULE HAS BEEN PUSHED BACK INTO THE HANDLE BODY ALLOWING THE INSERTION TUBE TO MOVE AROUND FREELY. BIO DEBRIS IS INSIDE THE TUBE. THE CLEAT IS FULLY EXTENDED. A MATERIAL ASSESSMENT COULD NOT BE PERFORMED DUE TO THE PART NOT BEING 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. A REVIEW OF THE MATERIAL SPECIFICATION FOUND THAT SUTURE STRENGTH REQUIREMENTS ARE SPECIFIED. A CERTIFICATE OF ANALYSIS IS REQUIRED WITH EACH SHIPMENT VERIFYING SUTURE DIAMETER & KNOT PULL SUTURE STRENGTH. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS. FACTORS THAT CAN CONTRIBUTE TO THE REPORTED EVENT INCLUDE EXCESSIVE FORCE OR CONTACT WITH A SHARP GRASPER/INSTRUMENT. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN OPEN ARFL RECONSTRUCTION PROCEDURE, THE SUTURE OF THE 1.8 Q FIX ANCHOR BROKE WHILE THE SUTURE WAS BEING LIGATED. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP. IT IS UNKNOWN WHETHER ANY DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351616 QFIX 1.8 MINI SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHROCARE CORPORATION 2181651 00885556662618

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown