BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP 4.0MM TAPERED TIP 6BOX ST

    MDR report key: 15437218 · Received September 16, 2022

    Report

    Report Number
    0002242056-2022-00008
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    August 22, 2022
    Report Date
    November 18, 2022
    Manufacturer
    A&E MEDICAL CORPORATION
    Product Code
    LRY
    UDI-DI
    10841291105183
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    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. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED 080-403 LOT 04527. A PIECE OF DEBRIS COULD BE SEEN INSIDE OF THE STERILE PACKAGING. THE PIECE WAS MEASURED PER INSPECTION CRITERIA AND IS NOT ACCEPTABLE. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED EVENT IS THE OPERATOR NOT FOLLOWING THE PROVIDED WORK INSTRUCTIONS DURING MANUFACTURING. 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 COMPLAINT (B)(4). DEVICE PRODUCT CODE: LRY. 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 AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE INCOMING INSPECTION AT THE WAREHOUSE, A TEAM MEMBER FOUND DEBRIS IN THE STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467314 RSP 4.0MM TAPERED TIP 6BOX ST PUNCH, SURGICAL LRY A&E MEDICAL CORPORATION N/A 04527 10841291105183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown