BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET DRIVER CONNECTING SCREW

    MDR report key: 21265325 · Received January 29, 2025

    Report

    Report Number
    0001825034-2025-00222
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Report Date
    May 28, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JEY
    PMA / PMN Number
    K063052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCTS: ITEM#: 41002, DRIVER CONNECTING SCREW; LOT#: 7982705. H3: 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D2; D4; G4. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6. THE FOLLOWING SECTIONS WERE CORRECTED: D4; H4. VISUAL EXAMINATION OF THE PROVIDED PHOTO IDENTIFIED THAT THE SCREW TIP IS CRACKED AND IS STILL CONNECTED TO THE SCREW TIP. AS NO PRODUCT WAS RETURNED OR ADDITIONAL PICTURES PROVIDED; FURTHER VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 TREND

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSTRUMENT WAS VERY WORN AND FRACTURED. THERE WAS NO REPORT OF A FOREIGN BODY RETAINED BY THE PATIENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751904 BIOMET DRIVER CONNECTING SCREW INSTRUMENT/TRAUMA JEY ZIMMER BIOMET, INC. 615960

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE.