BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP 3.5MM 6BOX ST

    MDR report key: 20545578 · Received October 28, 2024

    Report

    Report Number
    0002242056-2024-00030
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    October 2, 2024
    Report Date
    February 19, 2025
    Manufacturer
    A&E MEDICAL CORPORATION
    Product Code
    LRY
    UDI-DI
    20841291105142
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H4, H6, H10, H11 NO PRODUCT WAS RETURNED. FOR 080-351 LOT 24993 THERE APPEARS TO BE A REDDISH DEBRIS INSIDE OF THE PACKAGE. IT CANNOT BE DETERMINED WHAT THE DEBRIS IS. NO HAIR IS VISIBLE IN THE PICTURE. THE MOST LIKELY ROOT CAUSE IS THE HAIR/ DEBRIS ENTERING THE PACKAGE DURING THE PACKAGING PROCESS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS NON-CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS THE OPERATOR NOT FOLLOWING THE PROVIDED WORK INSTRUCTIONS DURING MANUFACTURING. THE REPORTED EVENT IS CONFIRMED, BASED ON PROVIDED PHOTOS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET (B)(4). G2: FOREIGN SOURCE: JAPAN CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE INCOMING INSPECTION AT A WAREHOUSE, A TEAM MEMBER FOUND A A FOREIGN SUBSTANCE IN THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1891311 RSP 3.5MM 6BOX ST PUNCH, SURGICAL LRY A&E MEDICAL CORPORATION N/A 24993 20841291105142

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown