BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5X3.5MM HT SD X-DR SCREW EA

    MDR report key: 5951385 · Received September 14, 2016

    Report

    Report Number
    0001032347-2016-00515
    Event Type
    Injury
    Date Received
    September 14, 2016
    Date of Event
    August 1, 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

    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

    IT WAS DISCOVERED THAT THE FIRST PRODUCT EVALUATION CONDUCTED ON THIS COMPLAINT WAS PERFORMED ON PARTS FOR ANOTHER COMPLAINT. A NEW PCE WAS OPENED FOR THE CORRECT PARTS FOR THIS COMPLAINT. THE PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCT IDENTITY HAS BEEN CONFIRMED IN THE EVALUATION. THE SCREW WAS VISUALLY EVALUATED WITH A DIGITAL MICROSCOPE AND REVEALED MODERATE SIGNS OF USE. FROM THE TIP VIEW, THE SCREW APPEARS TO BE DULLED FROM USE AND MUCH OF THE ANODIZATION HAS WORN OFF. THE VIEW OF THE HEAD REVEALS A BLADE WAS INSERTED AND THE CROSS THREADS HAVE BEEN SLIGHTLY DAMAGED. THE SCREW WAS FUNCTIONALLY TESTED AND WAS FOUND TO HAVE MAINTAINED GOOD RETENTION, BUT IT COULD NOT SUPPORT THE WEIGHT OF THE DRIVER. THE SCREW DID NOT FUNCTION AS INTENDED; THEREFORE THE COMPLAINT IS CONFIRMED. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT WAS DETERMINED TO BE USE OF EXCESSIVE FORCE AT AN IMPROPER ANGLE DURING THE INSERTION PROCESS, POTENTIALLY IN CONJUNCTION WITH DENSE PATIENT BONE. ACCORDING TO THE EVALUATION, THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS.

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

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED A SCREW WOULD NOT PENETRATE THE BONE DURING A PROCEDURE. IT WAS NOTED ANOTHER SCREW WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602772 1.5X3.5MM HT SD X-DR SCREW EA DRILLING SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention