BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FAST-FIX ASSEMBLY - CURVED

    MDR report key: 17623894 · Received August 25, 2023

    Report

    Report Number
    1219602-2023-01618
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    August 4, 2023
    Report Date
    September 29, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    03596010597205
    PMA / PMN Number
    K072322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE (B)(4). 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. 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. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). D4, LOT NO.: THE FOLLOWING ARE THE LOT NUMBERS REPORTED: 2110668 AND 2110669, HOWEVER, IT IS UNKNOWN WHICH OF THE TWO DEVICES CAUSED THE DELAY. D4, EXP. DATE: EXPIRATION DATES FOR EACH OF THE TWO LOTS REPORTED: 09-JAN-2028 (2110668) AND 08-JAN-2028 (2110669). H4, MGF. DATE: MANUFACTURING DATES FOR EACH OF THE TWO LOTS REPORTED: 09-JAN-2023 (2110668) AND 08-JAN-2023 (2110669).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR, TWO ULTRA FAST-FIX FAILED IN THE SAME WAY. THE T1 IMPLANT OF THE FIRST DEVICE DID NOT COME OUT AFTER SEVERAL PENETRATIONS WERE MADE ON THE MENISCUS. A SECOND DEVICE WAS USED AND THE SAME MALFUNCTION OCCURRED. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932002 ULTRA FAST-FIX ASSEMBLY - CURVED SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. UNKNOWN 03596010597205

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female