BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N

    MDR report key: 24250952 · Received February 3, 2026

    Report

    Report Number
    1219602-2026-00310
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    August 9, 2025
    Report Date
    May 12, 2026
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    UDI-DI
    03596010532190
    PMA / PMN Number
    K972326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 RETURNED IN ORIGINAL PACKAGING WITH THE BATCH NUMBER 2180782 ON THE LABEL. THE NEEDLES, SUTURE, AND ANCHOR WERE NOT RETURNED. THE DISTAL END OF THE SHAFT IS BENT. BIO DEBRIS IS PRESENT. 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 ANCHOR MATERIAL SPECIFICATION FOUND THAT NO BURRS, CRACKS, OR CONTAMINATION IS ALLOWED. A CERTIFICATION OF COMPLIANCE TO MATERIAL AND PROCESSING SPECIFICATIONS IS REQUIRED. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE INVESTIGATION. FACTORS THAT CAN CONTRIBUTE TO THE REPORTED EVENT INCLUDE AN INADVERTENT IMPACT EVENT THAT MAY HAVE OCCURRED DURING DEVICE TRANSPORTATION, ROUGH SHIPPING AND HANDLING, OR AT THE CUSTOMER SITE, AS WELL AS THE APPLICATION OF AN UNINTENDED, INAPPROPRIATE, OR EXCESSIVE FORCE TO THE DEVICE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    H11: 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. A REVIEW OF THE ANCHOR MATERIAL SPECIFICATION, FOUND THAT NO BURRS, CRACKS, OR CONTAMINATION IS ALLOWED. A CERTIFICATION OF COMPLIANCE TO MATERIAL AND PROCESSING SPECIFICATIONS IS REQUIRED. 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 THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE TWINFIX 3.5 SUTURE ANCHOR FRACTURED IN HALF WHEN IT WAS INSERTED IN THE BONE, THEY USED A 1.7 DRILL BIT TO PREVENT THE FRACTURE, BUT IT STILL OCCURRED. THE SUTURES OF THE ANCHOR CAME OUT OF THE PATIENT. THE ANCHOR WAS LEFT IN THE PATIENT'S BONE. THE PROCEDURE COULD NOT BE COMPLETED, AND NO OTHER SURGERY WAS PROGRAMMED. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601247 TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 2180782 03596010532190

    Patients

    Seq Age Sex Outcome Treatment
    1