BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-BLADE INSERTER GAMMA3®

    MDR report key: 4100461 · Received September 19, 2014

    Report

    Report Number
    0009610622-2014-00476
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRODUCT INQUIRY STATES THE U-BLADE INSERTER GAMMA3 TO BE THE SUBJECT PRODUCT. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. DIMENSIONAL INSPECTION OF THE RETURNED FRAGMENT (BROKEN OFF SPRING PIN) REVEALED THE DIAMETER BEING WITHIN SPECIFICATION. REVIEW OF THE MANUFACTURING RECORDS REVEALED NO DISCREPANCIES. THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE U-BLADE INSERTER HAD BEEN IN USE FOR A LONGER TIME (MANUFACTURED IN SEPTEMBER 2008), WE PRE-SUPPOSE THAT THE DEVICE HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED WITHOUT ANY PROBLEMS REPORTED. ONE OF TWO SPRING PINS THAT KEEP THE CLAMPING PLATE IN PLACE IS COMPLETELY BROKEN OFF AT THE TRANSITION TO THE BORE IN WHICH THE PIN IS EMBEDDED IN THE FRAME OF THE INSERTER. THE APPEARANCE OF THE BREAKAGE SURFACE OF THE BROKEN OFF PIN SHOWS FEATURES OF A FORCED BRITTLE FRACTURE. NO PLASTIC DEFORMATION IS VISIBLE. AN ATTEMPT TO REPRODUCE THE IDENTIFIED BREAKAGE BY OVER-BENDING THE REMAINING (INTACT) SPRING PIN DID NOT LEAD TO ANY BREAKAGE OR PLASTIC DEFORMATION AT ALL. THE FAILURE REPORTED COULD NOT BE REPRODUCED AND THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. NEVERTHELESS IT CAN BE ASCERTAINED THAT THE ROOT CAUSE IS NOT RELATED TO A DEFICIENCY OF THE DEVICE, BUT IS MOST LIKELY RELATED TO AN INTRA-OPERATIVE PROCEDURE. NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE SPRING PIN OF U-INSERTER BROKE.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE SPRING PIN OF U-INSERTER BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584037 U-BLADE INSERTER GAMMA3® ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K463650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other