BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5X4MM HT SD X-DR SCREW EA

    MDR report key: 5953250 · Received September 15, 2016

    Report

    Report Number
    0001032347-2016-00518
    Event Type
    Injury
    Date Received
    September 15, 2016
    Date of Event
    August 9, 2016
    Report Date
    August 17, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK121589
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCT IDENTITY WAS CONFIRMED IN THE EVALUATION. THE SCREW WAS VISUALLY EVALUATED WITH A DIGITAL MICROSCOPE. THE TIP OF THE SCREW APPEARS TO BE SHARP WITH MINOR SIGNS OF GREEN ANODIZATION WEARING OFF, INDICATIVE OF USE. THE SIDE VIEW OF THE VISUAL EVALUATION SHOWS SHARP THREADS ON THE SCREW WITH SOME WHITE RESIDUE, ALSO INDICATIVE OF USE. THE VIEW OF THE HEAD SHOWS SOME WEAR INDICATING THE SCREWS MAINTAINED GOOD RETENTION. THE SCREW WAS FUNCTIONALLY TESTED AND FUNCTIONED AS INTENDED; THEREFORE THE COMPLAINT WAS NOT CONFIRMED. THE MOST-LIKELY CAUSE WAS DETERMINED TO BE USE AT AN IMPROPER ANGLE DURING THE INSERTION PROCESS, POTENTIALLY WITH DENSE BONE. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED A SCREW WAS UNABLE TO PENETRATE THE BONE DURING A PROCEDURE. NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606667 1.5X4MM HT SD X-DR SCREW EA DRILLING SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention