BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHORT MAS INSERTER

    MDR report key: 4792315 · Received May 22, 2015

    Report

    Report Number
    0002242816-2015-00048
    Event Type
    Injury
    Date Received
    May 22, 2015
    Report Date
    April 22, 2015
    Manufacturer
    EBI, LLC.
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SHORT MAS INSERTER WITH Z-CONNECT, ITEM # LV00718, LOT # 715650 WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE ITEM CONFIRMED THE REPORTED EVENT. THE TIP OF THE INSERTER SHOWS WEAR FROM USE, AND THE LOBES ARE ROUNDED AT THE TIPS CONSISTENT WITH COUNTER-CLOCKWISE ROTATIONAL FORCE AT THE TIPS WITHOUT THE PENTALOBE FEATURE BEING FULLY SEATED IN THE SCREW. FUNCTIONAL TESTING WAS NOT DONE; THE VISUAL INSPECTION WAS SUFFICIENT TO CONFIRM THE EVENT. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED; THE PART INSPECTION PASSED AND THE ITEMS WERE RELEASED TO INVENTORY. THE HARDNESS OF THE CENTRAL SHAFT AT INSPECTION WAS MEASURED AT 51HRC, MEETING THE DESIGN SPECIFICATION OF = 48 HRC. THERE IS NO INDICATION THE MANUFACTURING CONTRIBUTED TO THE EVENT. THE PARTS WERE LIKELY CONFORMING WHEN THEY LEFT BIOMET CONTROL. THE TIPS OF THE PENTALOBE FEATURE ARE ROUNDED CONSISTENT WITH APPLIED TORQUE WHEN THE ADJUSTER WAS NOT FULLY SEATED IN THE SCREW HEAD. THE PROBABLE UNDERLYING ROOT CAUSE FOR THE DAMAGE IS TORQUE APPLIED TO THE INSTRUMENT WITHOUT THE TIP BEING FULLY SEATED IN THE SCREW. SUPPLEMENTAL REPORT THREE OF FOUR FOR THE SAME EVENT, REFERENCE 2242816-2015-00046-1 THROUGH -00049-1.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS ANTICIPATED, A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. FILE THREE OF FOUR FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED THE SURGEON HAD SOME ISSUES PUTTING IN ILIAC SCREWS. SEVERAL DRIVERS STRIPPED DURING ATTEMPTED INSERTION RESULTING IN A FORTY-FIVE MINUTE SURGICAL DELAY. NO ADVERSE EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335521 SHORT MAS INSERTER SCREW INSERTER/DRIVER HXX EBI, LLC. N/A 673130

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization