BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ULTRABUTTON DEV

    MDR report key: 16137327 · Received January 11, 2023

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    Report

    Report Number
    3006524618-2023-00030
    Event Type
    Injury
    Date Received
    January 11, 2023
    Report Date
    January 11, 2023
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K153186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF THE PMS-247 NEW ZEALAND ACL REGISTRY AD HOC REPORT FEB 2022 FROM NEW ZEALAND THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON REGISTRY REVIEW PMS-247 NEW ZEALAND ACL REGISTRY AD HOC REPORT FEB 2022, 1 PATIENT PRESENTED AN UNKNOWN TRAUMA AFTER AN ACL PROCEDURE USING A ULTRABUTTON. THE PATIENT REQUIRED AN ADDITIONAL SURGERY (REVISION BPB). PATIENT CURRENT STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909869 UNKNOWN ULTRABUTTON DEV FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHROCARE CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Required Intervention| H