BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREWDRIVER GAMMA3 380X110MM

    MDR report key: 3171402 · Received June 15, 2013

    Report

    Report Number
    0009610622-2013-00334
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 28, 2013
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION: EVENT DESCRIPTION SUGGESTS THE SCREWDRIVER AS PRIMARY PRODUCT. NO ASSOCIATED PRODUCTS WERE REPORTED. A REVIEW OF THE DHR COULD NOT BE CARRIED OUT AS THE LOT-CODE WAS NOT AVAILABLE. FORMER EVALUATION OF SIMILAR COMPLAINTS HAVE INDICATED THE SCREWDRIVER HAD BEEN OPERATED UNDER HIGH FORCE IN CCW / UNTIGHTENING DIRECTION, WHILST THE PEGS WERE NOT ENTIRELY ENGAGED IN THE SLOTS OF THE LAG SCREW. FORMER EVALUATION OF SIMILAR COMPLAINTS SUGGESTED THAT THE ITEM HAD NOT BEEN USED AS INTENDED. IT CANNOT BE EXCLUDED THAT THE ITEM HAD BEEN DAMAGED DURING FORMER SURGERIES BUT THE DAMAGE SHOULD THEN HAVE BEEN DETECTED DURING INSPECTION PRIOR TO SURGERY. THE ITEM WAS NOT RETURNED FOR INVESTIGATION. THUS A REAL ROOT CAUSE COULD NOT BE DETERMINED BUT FORMER EVALUATION OF SIMILAR COMPLAINTS REVEALED EVIDENCE THAT THE EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICE BUT IS RATHER RELATED TO IMPROPER HANDLING. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY WAS IDENTIFIED. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    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. AS THE LAG SCREWDRIVER HAD BEEN IN USE FOR A LONGER TIME (MANUFACTURED IN 2008) WE PRE-SUPPOSE THAT THE DEVICE HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. THE BROKEN OFF AND DAMAGED PEGS ARE A RESULT OF AN INADEQUATE USAGE. THE APPEARANCE OF THE DAMAGE AT THE TIP OF THE DRIVER INDICATES THAT THE SCREWDRIVER HAD BEEN OPERATED UNDER HIGH FORCE IN CCW / UNTIGHTENING DIRECTION, WHILST THE PEGS WERE NOT ENTIRELY ENGAGED IN THE SLOTS OF THE LAG SCREW. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE TIPS OF THE CANNULATED SCREWDRIVER, ONE OF THE 4 METAL TIP BROKE WHILE LOCKING SCREW IN IT'S FINAL POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE TIPS OF THE CANNULATED SCREWDRIVER, ONE OF THE 4 METAL TIP BROKE WHILE LOCKING SCREW IN IT'S FINAL POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE TIPS OF THE CANNULATED SCREWDRIVER, ONE OF THE 4 METAL TIP BROKE WHILE LOCKING SCREW IN IT'S FINAL POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272685 LAG SCREWDRIVER GAMMA3 380X110MM INSTRUMENT LXH STRYKER TRAUMA KIEL K505543

    Patients

    Seq Age Sex Outcome Treatment
    1 Other