BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSS GLENOID BASEPLATE IMPACTOR-S

    MDR report key: 15674243 · Received October 26, 2022

    Report

    Report Number
    3002788818-2022-00071
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    February 7, 2022
    Report Date
    December 29, 2022
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    LXH
    UDI-DI
    10381780467786
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: A PHOTOGRAPH OF THE PART WAS PROVIDED. EVALUATION OF THE PHOTOGRAPH IDENTIFIED THAT THE BLACK PLASTIC RADEL TIP OF THE IMPACTOR WAS BROKEN OFF. THE FAILURE WAS CONFIRMED. EVALUATION OF THE PHOTOGRAPH CONFIRMED THAT THE MOST LIKELY CAUSES FOR THE INSTRUMENT DAMAGE WERE EXCESSIVE FORCE OR OFF-AXIS LOADING WHEN IMPACTING. THIS COMPLAINT WAS ORIGINALLY CREATED IN THE INTEGRA LIFESCIENCES COMPLAINT MANAGEMENT SYSTEM. THIS COMPLAINT IS BEING MIGRATED INTO SMARTSOLVE AS COMPLAINT HANDLING FOR THIS PRODUCT HAS TRANSFERRED FROM INTEGRA TO SMITH+NEPHEW. AS SUCH, SOME DETAILS IN THE COMPLAINT RECORD MAY REPRESENT LEGACY INTEGRA COMPLAINT HANDLING PROCESSES. ENTRIES IN THIS RECORD ARE COPIED FROM LEGACY INTEGRA COMPLAINT MANAGEMENT SYSTEM RECORD (B)(4). PER THE LEGACY INTEGRA LIFESCIENCES COMPLAINT RECORD (B)(4), "A REVIEW OF THE [MANUFACTURING] LOT RECORDS IDENTIFIED NO ISSUES OR PROBLEMS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE FAILURE MODE ALLEGED BY THIS COMPLAINT". THEREFORE, THE DEVICE MET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. PER THE LEGACY INTEGRA LIFESCIENCES COMPLAINT RECORD (B)(4), "NO CAPA WILL BE INITIATED AS NO ADVERSE TREND WAS IDENTIFIED, THE SEVERITY LEVEL IS NOT HIGHER THAN ANTICIPATED, AND NO SIGNIFICANT NONCONFORMANCE OF REGULATORY REQUIREMENTS EXISTS". THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE BEING TAKEN.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A REVERSE SHOULDER REPLACEMENT SURGERY, THE PLASTIC END OF THE RSS GLENOID BASEPLATE IMPACTOR-S BROKE WHILE USING. NO PIECES FELL INSIDE OF THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2599479 RSS GLENOID BASEPLATE IMPACTOR-S ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ASCENSION ORTHOPEDICS, INC. IMP-0961-064-S 28064303 10381780467786

    Patients

    Seq Age Sex Outcome Treatment
    1 Male