BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM SYSTEM 1.65 X 5MM HIGH TORQUE SELF DRILLING CROSS DRIVE SCREW

    MDR report key: 10101040 · Received May 29, 2020

    Report

    Report Number
    0001032347-2020-00241
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 8, 2020
    Report Date
    August 26, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036134907
    PMA / PMN Number
    K121589
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS NON-VERIFIABLE. PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND NO PHOTOS WERE PROVIDED. FOR THESE REASONS, NO VISUAL INSPECTIONS OR FUNCTIONAL TESTING COULD BE CONDUCTED. THE DHR COULD NOT BE REVIEWED DUE TO THE LOT NUMBERS REMAINING UNKNOWN. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. FOR THIS PART (91-6105X) AND THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE), (B)(4). THE MOST LIKELY UNDERLYING CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT AN INSERTION ATTEMPT WAS MADE OFF AXIS, THE SCREWS WERE INSERTED INTO HIGH DENSITY BONE, OR WERE OVER-TORQUED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THE FOLLOWING FIELDS WERE UPDATED: B4 DATE OF THIS REPORT B5 DESCRIBE EVENT OR PROBLEM D10 DEVICE AVAILABILITY G4 DATE RECEIVED BY MANUFACTURER G7 TYPE OF REPORT H2 FOLLOW UP TYPE H3 DEVICE EVALUATED BY MANUFACTURER H6 METHOD CODE H6 RESULTS CODE H6 CONCLUSIONS CODE H10 ADDITIONAL NARRATIVES/DATA

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). 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. MEDICAL PRODUCTS: 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCREW 1.5MM X 5MM, PART# 91-6105., LOT# UNK. 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK, PART# 91-6104, LOT# UNK. HTR-PEKK COMPTO RT FT SP PA TE, PART# PK623109, LOT# 976410. 1.5MM SYSTEM 2X3 HOLE RECTANGLE PLATE, PART# 01-7136, LOT# UNK. 1.5MM SYSTEM 6 HOLE REGULAR DOUBLE Y PLATE, PART# 01-7110, LOT# UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO (2) SCREWS FRACTURED DURING IMPLANTATION OF A CUSTOM CRANIAL PLATE. THE PROCEDURE WAS COMPLETED WITH ALTERNATIVE SCREWS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564203 1.5MM SYSTEM 1.65 X 5MM HIGH TORQUE SELF DRILLING CROSS DRIVE SCREW PLATE, BONE JEY BIOMET MICROFIXATION N/A UNK 00841036134907

    Patients

    Seq Age Sex Outcome Treatment
    1