BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STER TRC 5 XD TF 1.5X4.0MM SCR

    MDR report key: 11655309 · Received April 13, 2021

    Report

    Report Number
    0001032347-2021-00203
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 15, 2021
    Report Date
    May 25, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    K972322
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    POSSIBLE LOT #S - 990240 OR 740300 A VISUAL INSPECTION WAS CONDUCTED ON THE SCREW. THE SCREW SHOWS SIGNS OF ATTEMPTED USE. THERE IS MARKING ON THE SCREW HEAD. THE SCREW HAS FRACTURED WHERE THE SCREW HEAD MEETS THE SCREW SHAFT. A DIMENSIONAL ANALYSIS CANNOT BE CONDUCTED DUE TO THE DAMAGE TO THE SCREW. MEDICAL RECORDS WERE NOT PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 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. 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 · 1

    IT WAS REPORTED THAT APPROXIMATELY FOUR (4) WEEKS AGO DURING SURGERY THE SCREW WAS INSERTED WITH FORCE DUE TO PATIENT HAVING HARD BONE. SUBSEQUENTLY, THE SCREW HEAD BROKE AND REMAINED IN THE PATIENT. SURGERY WAS COMPLETED WITH ANOTHER SCREW. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556432 STER TRC 5 XD TF 1.5X4.0MM SCR PROSTHESIS, MICROFIXATION JEY BIOMET MICROFIXATION NI SEE NARRATIVE IN H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other