BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SBG STEM WITH HA 5 R

    MDR report key: 11889997 · Received May 26, 2021

    Report

    Report Number
    9613369-2021-00266
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    May 10, 2021
    Report Date
    September 23, 2021
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G3, H2, H3, AND H6: IT WAS REPORTED THAT, DURING SURGERY, A HAIR WAS FOUND IN THE INNER STERILE PACKAGING OF THE SBG STEM WITH HA 5 R. THE DEVICE WAS NOT IMPLANTED IN THE PATIENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT SIGNIFICANT DELAYS (5 MINUTES). THE PATIENT WAS NOT HARMED. THE PRODUCT INCLUDING PACKAGING WAS RETURNED FOR INVESTIGATION. THE REPORTED HAIR IS CLEARLY VISIBLE INSIDE THE PEEL BAGS. THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR INVESTIGATION TO OUR PACKAGING SUPPLIER. THE HAIR IS ON THE BACK OF THE LABEL, WHICH WAS STUCK ON THE FIRST BAG. THE HAIR MUST HAVE COME UNDER THE LABEL WHILE THE LABELS WERE BEING STUCK ON THE INNER PEEL BAG. SINCE THE HAIR WAS ON THE OUTSIDE OF THE PRIMARY BAG, THERE WAS NO DIRECT CONTACT WITH THE PRODUCT. THE STERILE BARRIER IS NOT IMPAIRED. THE BATCH RECORD WAS REVIEWED. NO DEVIATION WAS FOUND, NEITHER IN THE SPECIFIC MANUFACTURING/ORDER DOCUMENTATION NOR IN THE STERILIZATION CERTIFICATE. FURTHERMORE THE PACKAGING SUPPLIER WAS INFORMED AND PERFORMED A REVIEW OF HIS DOCUMENTATION, NO DEVIATIONS WERE FOUND AS WELL. IN OUR CURRENT IFU FOR HIP IMPLANTS LIT. 12.23/ED.05 IT IS LISTED THAT THE DEVICE SHOULD BE INSPECTED BEFORE USE. IMPLANTS SHOULD NOT BE USED IF THE PACKAGING SHOWS ANY DAMAGE OR FOREIGN BODIES. THE RISK IS COVERED IN OUR CORRESPONDING RISK FILE. THE ROOT CAUSE FOR THIS FAILURE WAS ESTABLISHED TO QUALITY CONTROL DEFICIENCY. THE REPORTED HAIR WAS OVERLOOKED DURING THE VISUAL INSPECTION DURING AND AFTER PACKAGING. A RETRAINING OF THE STAFF AT OUR PACKAGING SUPPLIER WAS PERFORMED. ADDITIONAL PREVENTIVE OR CORRECTIVE ACTIONS ARE NOT PLANNED. THIS CASE WILL BE CLOSED. SMITH & NEPHEW WILL MONITOR THIS DEVICE FOR SIMILAR ISSUES. B5: UPDATE SUMMARY. D8 AND D9: DEVICE RETURNED. G2: REPORT SOURCE UPDATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING SURGERY, A HAIR WAS FOUND IN THE INNER STERILE PACKAGING OF THE SBG STEM WITH HA 5 R. THE DEVICE WAS NOT IMPLANTED IN THE PATIENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT SIGNIFICANT DELYAS (5 MINUTES). THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING INSPECTION IN SURGERY, A HAIR WAS FOUND IN THE INNER STERILE PACKAGING OF THE SBG STEM WITH HA 5 R. THE DEVICE WAS NOT IMPLANTED IN THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A DELAY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787472 SBG STEM WITH HA 5 R SBG STEM WITH HA 5 R JWH SMITH & NEPHEW ORTHOPAEDICS AG A1803354

    Patients

    Seq Age Sex Outcome Treatment
    1