BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL TARGETING DEVICE GAMMA3® DISTAL TARGETING R1.5

    MDR report key: 3946150 · Received July 21, 2014

    Report

    Report Number
    0009610622-2014-00349
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A REVIEW OF THE MANUFACTURING RECORDS REVEALED NO DISCREPANCIES. THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. A FUNCTIONAL TEST (SAMPLE PROXIMAL TARGETING DEVICE, SAMPLE INSTRUMENTS AND SAMPLE NAIL WERE USED) REVEALED NO SERIOUS CONTACTS OF THE DRILL TO THE DISTAL DRILL HOLES. THE FUNCTION OF THE DISTAL TARGET RETURNED WAS FULLY GIVEN. THE ITEM HAD FULFILLED ITS TASKS FOR ROUGHLY 5 YEARS WITHOUT REPORTED DEVIATION. NO ADVERSE CONSEQUENCES WERE REPORTED. THE SURGEON HAD SOLVED THE SITUATION BY ADJUSTING THE SLEEVES. THE DISTAL TARGETING SYSTEM CONSISTS AMONG OTHERS OF AN ADJUSTING DEVICE WHICH IS INTENDED FOR HORIZONTAL ADJUSTMENT OF THE DRILL. SLIGHT NAIL CONTACT IN AXIAL DIRECTION WAS SUGGESTED BEING UNLIKELY TO CAUSE EARLY FAILURE BECAUSE POTENTIAL CONTACT AT DISTAL EDGE WOULD NOT BE AT RISK FOR BREAKAGE AS THE MAIN LOAD APPLICATION IS IN DIRECTION OF CROSS SECTION AND NOT IN AXIAL DIRECTION. THIS WAS ALSO SOLVED BY THE SURGEON WHILST ADJUSTING THE SLEEVE. THE EXACT ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. NEVERTHELESS, BASED ON THE ABOVE FACTS IT WAS SUGGESTED THAT THE SURGEON HAD FOLLOWED THE OP-TECH WHICH INSTRUCTS TO USE THE ADJUSTMENT DEVICE (WITH ENGAGED SLEEVES) IN ORDER TO ENSURE CORRECT DRILLING. THE ALLEGED EVENT WAS NOT CAUSED BY ANY DEFICIENCY OF THE DEVICE. THE CAUSE CAN ONLY BE FOUND IN THE INTRA-OPERATIVE PROCEDURE.

    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 G3 LONG NAIL SURGERY, THE SURGEON PERFORMED CALIBRATION COMBINING THE TARGET ARM AND DTD AND NAIL. WHEN THE SURGEON INSERTED THE DRILL BIT IN DISTAL SCREW HOLE OF THE NAIL, THE DRILL BIT CONTACTED THE NAIL(THE UPPER AND LOWER SIDES OF SCREW HOLE). THEREFORE THE SURGEON DID THE DRILL, ADJUSTING THE SLEEVE.

    Description of Event or Problem · 1

    DURING G3 LONG NAIL SURGERY, THE SURGEON PERFORMED CALIBRATION COMBINING THE TARGET ARM AND DTD AND NAIL. WHEN THE SURGEON INSERTED THE DRILL BIT IN DISTAL SCREW HOLE OF THE NAIL, THE DRILL BIT CONTACTED THE NAIL(THE UPPER AND LOWER SIDES OF SCREW HOLE). THEREFORE THE SURGEON DID THE DRILL, ADJUSTING THE SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425055 DISTAL TARGETING DEVICE GAMMA3® DISTAL TARGETING R1.5 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL KP304941

    Patients

    Seq Age Sex Outcome Treatment
    1 Other