BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5X60MM CORT LOCK SCR STE

    MDR report key: 15770293 · Received November 10, 2022

    Report

    Report Number
    0001825034-2022-02509
    Event Type
    Malfunction
    Date Received
    November 10, 2022
    Date of Event
    October 24, 2022
    Report Date
    December 6, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    UDI-DI
    00887868352058
    PMA / PMN Number
    K143697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: 3.5X60MM CORT LOCK SCREW CAT #: 856135060 LOT# 942790 QTY OF 9 TOTAL. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2022 - 02436, 0001825034 - 2022 - 02510, 0001825034 - 2022 - 02511, 0001825034 - 2022 - 02512, 0001825034 - 2022 - 02513, 0001825034 - 2022 - 02514, 0001825034 - 2022 - 02515, 0001825034 - 2022 - 02516.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. -VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THERE IS A SCRATCH ON THE INNER POUCH ON ALL 9 PRODUCTS. THE SCRATCH DOES NOT GO THROUGH THE POUCH. STERILITY HAS NOT BEEN COMPROMISED. THIS COMPLAINT HAS BEEN CONFIRMED. -REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. -A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. - UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. 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 WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCT WAS NONCONFORMING, AS THE STERILE PACKAGE HAD SCRATCH MARKS ON IT. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    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
    1060064 3.5X60MM CORT LOCK SCR STE SCREW, PROSTHESIS HRS ZIMMER BIOMET, INC. N/A 942790 00887868352058

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10.