BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE ANCHORS SPARE, STERILE

    MDR report key: 11996894 · Received June 14, 2021

    Report

    Report Number
    3003604053-2021-00221
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    May 21, 2021
    Report Date
    October 22, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    UDI-DI
    00854501006111
    PMA / PMN Number
    K131635
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW OF THIS PART NUMBER CONCLUDED THIS WAS AN ISOLATED EVENT. A REVIEW OF THE DEVICE LABEL REVEALED AN EXPIRATION DATE OF 2023-01-30. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. A REVIEW OF THE PACKAGING STORAGE STABILITY REPORT FOUND THE DEVICE HAS BEEN VALIDATED FOR A SHELF LIFE OF THREE YEARS. AFTER A REVIEW OF INTERNAL RECORDS, IT WAS CONFIRMED THAT THE EXPIRATION DATE FOR CATALOGUE ITEM 2503-S, BONE ANCHORS SPARE, STERILE, LOT 2050408 IS JANUARY 2023 AND THE ITEM WAS NOT EXPIRED AT THE TIME OF IMPLANTATION. SINCE NO PATIENT INJURIES ARE ANTICIPATED NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE WAS ASSOCIATED WITH MANUFACTURING. THERE WAS A MISMATCH IN THE MANUFACTURING PRODUCTION SYSTEMS. AN ENGINEERING CHANGE ORDER WAS ISSUED TO CORRECT THE EXPIRATION DATE IN THE PRODUCTION DATABASE.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT BOX INDICATED AN EXPIRATION DATE OF JANUARY 2023 BUT THE CORRECT EXPIRATION DATE WAS JANUARY 2021. THE LABEL WAS PRINTED INCORRECTLY. THE BONE ANCHOR OPERATED AS EXPECTED AND THIS WAS NOTICED AFTER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892621 BONE ANCHORS SPARE, STERILE FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 2050406 00854501006111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other