BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #0

    MDR report key: 21158906 · Received January 15, 2025

    Report

    Report Number
    0001032347-2025-00015
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Report Date
    May 9, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D4 . THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10, G3, G6, H2, H3, H4, H6, H10, H11. D4: THE UDI ORIGINALLY REPORTED IS NOT VALID AS THE MANUFACTURE DATE OF THE DEVICE IS PRIOR TO UDI ADOPTION FOR THE DEVICE. PLEASE CONSIDER UDI BLANK. D10: ELEVATOR #0 CAT# 09-0258 LOT#L12. ELEVATOR #0 CAT# 09-0258 LOT#C13. CRANE PICK ELEVATOR CAT# 09-0262 LOT# 00376350. CRANE PICK ELEVATOR CAT# 09-0262 LOT# 00376350. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED ELEVATOR. D15, SHOWED SIGNS OF MULTIPLE USES INCLUDING HEAVY MARKING AND SCRATCHING ON THE ELEVATOR SURFACES. ADDITIONAL INSPECTION SHOWED THAT THE ELEVATOR TIP HAS FRACTURED. A FRACTURE ANALYSIS WAS NOT CONDUCTED AS THE PRODUCT SHOWS SIGNS OF MULTIPLE USES AND PRODUCT HAS BEEN IN THE FIELD APPROXIMATE 10 YEARS AND THERE IS NO INDICATION THAT A MANUFACTURING DEFICIENCY OCCURRED. DHR REVIEW WAS NOT PERFORMED AS PRODUCT HAS APPROXIMATE FIELD AGE OF 10 YEARS, WITH AN UNKNOWN NUMBER OF USES. THE DEVICE SHOWS SIGNS OF REPEATED USE. THE DEVICE WAS RETURNED TO THE SUPPLIER FOR INVESTIGATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS CONFIRMED, BASED ON PRODUCT RETURN. 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.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE ELEVATOR FRACTURED DURING A PROCEDURE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583523 ELEVATOR #0 ELEVATOR, SURGICAL, DENTAL EMJ BIOMET MICROFIXATION N/A D15

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown