BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTUREFIX ULTRA AHR S 2 UB STR BLUE

    MDR report key: 15786518 · Received November 14, 2022

    Report

    Report Number
    1219602-2022-01715
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    May 3, 2021
    Report Date
    January 22, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    UDI-DI
    00885554030037
    PMA / PMN Number
    K122059
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). LOT #: THE FOLLOWING ARE THE LOT NUMBERS REPORTED: 2049958, 2057409, 2052186, 2049956 AND 2059878 HOWEVER, IT IS UNKNOWN WHICH OF THE 5 FAILED. EXP. DATE: EXPIRATION DATES FOR EACH OF THE 5 LOTS REPORTED: 23-JAN-2025 (2049958)16-JUN-2025 (2057409), 28-FEB-2025 (2052186), 22-JAN-2025 (2049956), 03-SEP-2025 (2059878). MGF. DATE: MANUFACTURING DATES FOR EACH OF THE 5 LOTS REPORTED: (B)(6) 2020 (2049958), (B)(6) 2020 (2057409), (B)(6) 2020 (2052186), (B)(6) 2020 (2049956), (B)(6) 2020 (2059878).

    Additional Manufacturer Narrative · 0

    H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION REVEALED THAT THE ITEM WAS NOT RETURNED IN ANY ORIGINAL PACKAGING. THE FULL DEVICE WAS NOT RETURNED, ONLY THE FORK WAS RETURNED. THE TINES ARE NOT DAMAGED. THE NECK BETWEEN THE TINES AND THE BREAK IS BENT AND SHOW SIGNS OF SHARP INSTRUMENT(S) TOUCHING IT. THE LOWER NECK OF THE FORK HAS BEEN SHEERED FROM ITS BASE. THE EDGE, AT THE BREAK, IS ROLLED TO ONE SIDE INDICATING IT WAS FOLDED OVER AND STRESSED TO THE POINT OF BREAKING. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WERE 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 AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A CLINICAL REVIEW STATES THAT THE RETAINED ¿METAL INSERTER TIP¿ WAS REPORTEDLY FOUND IN THE GLENOID BONE APPROXIMATELY ONE AND A HALF YEARS AFTER THE PROCEDURE WAS ALREADY COMPLETED. THE IFU CAUTIONS STATES ¿ONLY USE THE RECOMMENDED DRILL BITS AND DRILL GUIDES INTENDED FOR USE WITH THE SUTUREFIX ULTRA SUTURE ANCHOR. USE OF OTHER INSTRUMENTS MAY INJURE THE PATIENT, DAMAGE THE INSTRUMENTS, OR COMPROMISE FIXATION.¿ THE SUTUREFIX INSERTION DEVICES ARE MANUFACTURED AND INTENDED AS EXTERNALLY COMMUNICATING DEVICES AND ARE NOT APPROVED FOR LONG TERM INTERNAL TISSUE EXPOSURE AND LONG-TERM IMPLANTATION DATA IS NOT AVAILABLE. THE PATIENT IMPACT BEYOND POSSIBLE MICRO-MOTION AND/OR MIGRATION, AND LOCAL IRRITATION/DISCOMFORT CANNOT BE DETERMINED. THE ROOT CAUSE HAS BEEN ASSOCIATED WITH UNINTENDED USE OF THE DEVICE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE FAILURE INCLUDE USE OF EXCESSIVE FORCE UPON INSERTION OR CONTACT WITH ANOTHER SOURCE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANTATION FIVE (5) SUTUREFIX ULTRA ANCHOR´S WERE USED, AND ONE THE METAL INSERTER TIP SHEARED OFF INSIDE THE PATIENT´S GLENOID, ALTHOUGH IT IS UNKNOWN WHICH ONE OF THE FIVE REPORTED DEVICES; THIS ISSUE WAS NOT VISIBLE WHEN IMPLANTED AND THE ITEM IS UNDERNEATH THE REPAIRED LABRUM INSIDE THE BONE. THE METAL WAS NOTICED ON SECOND LOOK IMAGING IN THE PHYSICIAN´S OFFICE. SURGERY WAS COMPLETED WITH THE REPORTED DEVICES WITHOUT ANY DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353137 SUTUREFIX ULTRA AHR S 2 UB STR BLUE FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 72203852 UNKNOWN 00885554030037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other