BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5X7MM HT SD X-DR SCR 5-PK

    MDR report key: 11938925 · Received June 4, 2021

    Report

    Report Number
    0001032347-2021-00336
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    April 20, 2021
    Report Date
    June 25, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036056681
    PMA / PMN Number
    K121589
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED. HOWEVER, A VISUAL INSPECTION WAS CONDUCTED ON THE CUSTOMER PROVIDED PICTURES. THE SCREWS BOTH SHOW HEAVY SIGNS OF USE. THERE IS HEAVY MARKING ON BOTH SCREW HEADS. BOTH SCREW SHAFTS HAVE FRACTURED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00335. CONCOMITANT MEDICAL PRODUCTS: ITEM# 95-6107; LOT# 823870. ITEM# 95-6107; LOT# 823870. ITEM# 95-6107; LOT# 823870. ITEM# 95-6107; LOT# 823870. ITEM# 95-6107; LOT# 823870. FULL ESTABLISHMENT NAME - (B)(6). FOREIGN - EVENT OCCURRED IN (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 DURING AN INITIAL PROCEDURE APPROXIMATELY SIX (6) WEEKS AGO, TWO (2) OF THE SIX (6) NAILS BEING USED BROKE AND WAS RETAINED BY THE PATIENT. ONE SCREW BROKE WHILE BEING INSERTED AND THE SECOND SCREW DID NOT SEAT PROPERLY AND BROKE WHEN THE SURGEON TRIED TO REMOVE IT. PATIENT HAS NOT EXPERIENCED ANY POST-SURGERY COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837742 1.5X7MM HT SD X-DR SCR 5-PK PROSTHESIS, MICROFIXATION JEY BIOMET MICROFIXATION NI 823870 00841036056681

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other