BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTUREFIX ULTRA AHR S

    MDR report key: 17680084 · Received September 4, 2023

    Report

    Report Number
    1219602-2023-01698
    Event Type
    Malfunction
    Date Received
    September 4, 2023
    Date of Event
    August 16, 2023
    Report Date
    November 4, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    PMA / PMN Number
    K122059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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, PART NO.: THE FOLLOWING ARE THE PART NUMBERS REPORTED: 72203853 AND 72203854. LOT NO.: THE FOLLOWING ARE THE LOT NUMBERS REPORTED: 2099551 AND 2101952 D4, EXP. DATE: EXPIRATION DATES FOR EACH OF THE -X QUANTITY- LOTS REPORTED: 01-SEP-2027 (2099551), 30-SEP-2027 (2101952) H4, MGF. DATE: MANUFACTURING DATES FOR EACH OF THE -X QUANTITY-LOTS REPORTED: 01-SEP-2022 (2099551), 30-SEP-2022 (2101952).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ANCHOR OF TWO (2) SUTUREFIX ULTRA WERE NOT HOLDING TO THE BONE. BOTH ANCHORS GOT PULLED OUT. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889515 SUTUREFIX ULTRA AHR S FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown