BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWINFIX ULTRA HA 4.5 W/2 UB (WH & BLUE

    MDR report key: 13285415 · Received January 18, 2022

    Report

    Report Number
    1219602-2022-00096
    Event Type
    Injury
    Date Received
    January 18, 2022
    Date of Event
    December 29, 2021
    Report Date
    February 23, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MAI
    UDI-DI
    03596010647559
    PMA / PMN Number
    K151105
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    H2: ADDITIONAL INFORMATION ¿B5: EVENT DESCRIPTION¿ H3, H6: ¿THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. IT WAS DETERMINED THE DEVICE DID NOT CONTRIBUTE TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A REVIEW OF THE POLYMER FOUND THAT THE STORAGE REQUIREMENTS FOR THE MATERIAL ARE SPECIFIED, AND THE MATERIAL MUST COMPLY WITH PROVIDED PERCENTAGE COMPOSITION SPECIFICATIONS AS MEASURED BY ASH TEST. A REVIEW OF THE CUSTOMER PROVIDED IMAGE FOUND LABELLING CONFIRMING THE PRODUCT IDENTIFICATION INFORMATION. THE ANCHOR IS ON THE SHAFT OF THE DEVICE, AND IS FRACTURED ON THE DISTAL END. A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT IT IS NOT IN ITS ORIGINAL PACKAGING. THE DEVICE HAS NOT BEEN DEPLOYED, AND THE ANCHOR IS FRACTURED ON THE DISTAL END THROUGH THE SUTURE WINDOW. THE PRONGS ON THE DISTAL END OF THE SHAFT ARE BENT. THERE IS DEBRIS ON THE DEVICE. BASED ON THE CONDITION OF THE PRODUCT MATERIAL FOUND DURING VISUAL INSPECTION, ADDITIONAL MATERIAL TESTING IS NOT REQUIRED. A REVIEW OF THE COMPLAINT REVEALED THERE WERE NO PATIENT INJURIES REPORTED AND NO APPARENT PATIENT IMPACT BASED ON THE DETAILS PROVIDED. THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED. THE COMPLAINT WAS CONFIRMED, AND THE ROOT CAUSE WAS ASSOCIATED WITH UNINTENDED USE OF THE DEVICE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE EXCESSIVE FORCE ON THE DEVICE, EXCESSIVE TORQUE ON THE DEVICE, ATTEMPTED CORRECTION OF A DAMAGED DEVICE, OFF-AXIS INSERTION, IMPROPER PREPARATION OF THE INSERTION SITE, OR AN INADVERTENT IMPACT EVENT INCONSISTENT WITH NORMAL USE. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. ¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A SURGERY THE TWINFIX ANCHOR WAS FOUND FRACTURED DURING IMPLANTATION. ALL THE PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK UP DEVICE. THERE WAS NOT A SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A SURGERY THE TWINFIX ANCHOR WAS FOUND FRACTURED DURING IMPLANTATION. ALL THE PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK UP DEVICE IN THE ORIGINAL DRILLED BONE HOLE. THERE WAS NOT A SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917666 TWINFIX ULTRA HA 4.5 W/2 UB (WH & BLUE FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI SMITH & NEPHEW, INC. 72202597 50911094 03596010647559

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention| O