BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING SURGICAL PUNCHES 4.0MM 6BOX ST

    MDR report key: 19519522 · Received June 12, 2024

    Report

    Report Number
    0002242056-2024-00010
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    March 25, 2024
    Report Date
    October 11, 2024
    Manufacturer
    A&E MEDICAL CORPORATION
    Product Code
    LRY
    UDI-DI
    20841291105166
    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. A VISUAL INSPECTION WAS CONDUCTED ON THE TWO RETURNED PUNCHES. THE PUNCHES WERE RETURNED OUTSIDE OF THE PACKAGING AND SHOWED SIGNS OF ATTEMPTED USE INCLUDING DEBRIS ON THE TIP CUTTING SURFACES. THE PLUNGERS FOR BOTH PUNCHES WERE PULLED BACK AND THE CUTTING TIP FULLY RETRACTED INTO THE PUNCH BODY ON BOTH PUNCHES. THE CUTTING ACTION APPEARS TO BE WORKING AS IT SHOULD ON BOTH PUNCHES. THE CAPS FOR THE PUNCHES WERE FULLY SEATED WHEN RECEIVED. THE CAPS WERE REMOVED AND RE-INSTALLED AND LOCKED IN PLACE AS DESIGNED. THE COMPLAINT IS UNABLE TO BE CONFIRMED. THE SHARPNESS OF THE BLADES IS UNABLE TO BE TESTED DUE TO ATTEMPTED PRODUCT USE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS: ITEM# 080-401, LOT# 09419, ROTATING SURGICAL PUNCHES 4.0MM 6BOX ST. 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 THAT THE SURGICAL PUNCHES WERE NOT SHARP ENOUGH WHEN USED ON A 28 MM ARTIFICIAL BLOOD VESSEL. THERE WAS NO HARM OR DELAY IN PROCEDURE. ANOTHER PUNCH WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188755 ROTATING SURGICAL PUNCHES 4.0MM 6BOX ST PUNCH, SURGICAL LRY A&E MEDICAL CORPORATION N/A 09419 20841291105166

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown