BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREWDRIVER GAMMA3® 380X110MM

    MDR report key: 3852600 · Received June 6, 2014

    Report

    Report Number
    0009610622-2014-00269
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED DEVICE MATCHED THE REPORT AND THE REPORTED EVENT WAS CONFIRMED. REVIEW OF THE MANUFACTURING RECORDS REVEALED NO DISCREPANCIES. THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. ONE OF THE FOUR PEGS IS COMPLETELY BROKEN OFF. MATERIAL DISPLACEMENT IS VISIBLE. THE REMAINING PEGS ARE SIGNIFICANTLY BENT AND DEFORMED. THE TIP OF THE INNER ROD IS FURTHERMORE DEFORMED AND DAMAGED. THE BROKEN OFF AND DAMAGED PEGS ARE A RESULT OF AN INADEQUATE USAGE. THE APPEARANCE OF THE DAMAGE INDICATES THAT THE LAG SCREWDRIVER HAD BEEN OPERATED UNDER HIGH FORCES IN CCW / UNTIGHTENING DIRECTION, WHILST THE PEGS WERE NOT ENTIRELY ENGAGED IN THE SLOTS OF THE LAG SCREW. THE HEAVILY ABRADED AND PLASTICALLY DEFORMED THREAD WINDINGS ARE MOST LIKELY THE RESULT OF AN OBLIQUE ADAPTING UNDER HIGH FORCE APPLICATION. IN CASE OF INTENDED USE SUCH DAMAGE WOULD NOT HAVE OCCURRED. A PRE-DAMAGING OF THE INSTRUMENT IN PRIOR SURGERIES COULD NOT BE EXCLUDED. BASED ON THE ABOVE FACTS THE ROOT CAUSE OF THE REPORTED EVENT IS NOT RELATED TO A DEFICIENCY OF THE DEVICE, BUT IS RATHER LINKED TO IMPROPER HANDLING BY THE USER. NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A GAMMA NAIL REMOVAL AND CONVERSION TO A RIGHT TOTAL HIP DUE A NON-UNION. UPON ATTEMPTING TO REMOVE THE GAMMA NAIL THE LAG SCREW INSERTER GEAR WAS SHEARED OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A GAMMA NAIL REMOVAL AND CONVERSION TO A RIGHT TOTAL HIP DUE A NON-UNION. UPON ATTEMPTING TO REMOVE THE GAMMA NAIL THE LAG SCREW INSERTER GEAR WAS SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332555 LAG SCREWDRIVER GAMMA3® 380X110MM INSTRUMENT LXH STRYKER TRAUMA KIEL K0F30F9

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR