BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD

    MDR report key: 16701619 · Received April 7, 2023

    Report

    Report Number
    0001822565-2023-00960
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    February 17, 2023
    Report Date
    August 21, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    UDI-DI
    00889024094116
    PMA / PMN Number
    K082770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2023-00959, 0001822565-2023-00961. CONCOMITANT MEDICAL PRODUCTS: 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD, CAT: 47248403250, LOT: 65613735. UNKNOWN TARGETING JIG. CMN FEMORAL NAIL, CCD 125°, RIGHT, ø 11.5 MM, 21.5 CM, CAT: 47249321011, LOT: 3143338. ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 115 MM INCLUDING SET SCREW, CAT: 47248511510, LOT: 3093322. REPORT SOURCE: FOREIGN: FRANCE. 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 REPORT WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT WAS DETERMINED THAT THE GUIDE CAUSED THE SCREWS TO MISALIGN AND THE SCREWS DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT. THE EVENT WILL BE INVESTIGATED ON MEDWATCH #0001822565-2023-00961. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 THAT THE SURGEON WAS IMPLANTING A PERITROCHANTERIC NAIL, AFTER SPEAKING WITH THE CONTROL TEAM DURING THE OPERATION, IT WAS NOTED THAT THE SCREWS HAD BEEN IMPLANTED ABOVE THE NAIL HOLES. THE NAIL WAS REMOVED AND REPLACED WITH ANOTHER BACK UP PRODUCT DURING THE SAME SURGERY. THE SURGEON IS CONCERNED THAT THE TARGETING INSTRUMENT HAD CONTRIBUTED TO THE FAILURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 0

    IT WAS DETERMINED THAT THE GUIDE CAUSED THE SCREWS TO MISALIGN AND THE SCREWS DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT. THE EVENT WILL BE INVESTIGATED ON MEDWATCH #0001822565-2023-00961.

    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
    1754547 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD SCREW, FIXATION HSB ZIMMER BIOMET, INC. 47-2484-045-50 65378233 00889024094116

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male SEE H10.