BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HOLDING SCREW GAMMA3® 8X35MM

    MDR report key: 5308544 · Received December 17, 2015

    Report

    Report Number
    0009610622-2015-00598
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Date of Event
    December 2, 2015
    Report Date
    December 2, 2015
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE EVALUATION REVEALED THE TARGET DEVICE AND NAIL HOLDING SCREW (NHS) TO BE THE PRIMARY PRODUCTS. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). BOTH INSTRUMENTS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE TARGET DEVICE HAD BEEN IN USE FOR APPROX. 11 YEARS AND THE NHS FOR APPROX. 4 YEARS IT CAN BE SUPPOSED THAT BOTH INSTRUMENTS HAD FULFILLED THEIR TASKS IN FORMER SURGERIES AS INTENDED. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. NO SIGNIFICANT DAMAGES WERE FOUND THAT EXPLAINS THE JAMMING OF THE NHS WITHIN THE TARGET DEVICE¿S METAL NAIL ADAPTER BUT BOTH ITEMS WERE HEAVILY POLLUTED WITH INCRUSTED BODY RESIDUES. IT WAS VISIBLE THAT THE RESIDUES DOWNSIZED THE INNER DIAMETER OF THE NAIL ADAPTER CONNECTION ROD; THEREFORE THE RESIDUES CAUSED THE JAMMING OF THE NHS. HOW THE RESIDUES GOT BETWEEN CONNECTION ROD AND NHS COULD NOT BE CLARIFIED BUT TWO SCENARIOS MOST LIKELY HAPPENED: SCENARIO 1: THE TARGET DEVICE WAS POLLUTED DURING A PREVIOUS SURGERY AND THE TARGET DEVICE WAS NOT OR INSUFFICIENT CLEANED AND THEN STERILIZED THAT LED TO AN INCRUSTATION OF THE RESIDUES. AFTER RE-ASSEMBLING OF THE NHS AND TARGET DEVICE THE INCRUSTED RESIDUES LED TO THE JAMMING. SCENARIO 2: THE NHS WAS REMOVED FROM THE NAIL AND TARGET DEVICE DURING THE REPORTED SURGERY DUE TO UNKNOWN REASON AND WAS RE-ASSEMBLED, SO BODY RESIDUES WERE SQUEEZED BETWEEN NHS AND CONNECTION ROD AND CAUSED THE JAMMING. AN EXCESSIVE TIGHTENING OF THE NHS CANNOT BE EXCLUDED AND DID MOST LIKELY ALSO CONTRIBUTE TO THE JAMMING. THE IFU AND INSTRUCTIONS FOR CLEANING, STERILIZATION, INSPECTION AND MAINTENANCE INCLUDE THAT EVERY INSTRUMENT MUST BE CLEANED, STERILIZED AND CHECKED SUCCESSFULLY PRIOR TO EVERY SURGERY. FURTHERMORE THE USER SHALL BE TRAINED AND FAMILIAR WITH THE SYSTEM AND OPERATIVE TECHNIQUES. A DETACHMENT OF THE NHS BEFORE END CAP INSERTION IS NOT NECESSARY ACCORDING TO THE OPERATIVE TECHNIQUE. BECAUSE NO MANUFACTURER RELATED ISSUES WERE FOUND THE JAMMING OF THE INSTRUMENTS IS RELATED TO THE USER. REGARDING SECONDARY FOUND ISSUES: THE CRACK WITHIN THE CFR-MATERIAL WAS CAUSED BY MULTIPLE STERILIZATION CYCLES (LONG TIME USAGE). THE MATERIAL WAS CHANGED TO IMPROVE THE STIFFNESS OF THE TARGET DEVICE WITH CHANGE REQUEST ECN 6053/07. HITTING MARKS IN TARGET DEVICES (MISUSE) ARE KNOWN FROM PREVIOUS CASES. TO AVOID THAT THE TARGET DEVICE GOT HIT DIRECTLY A SLOT WAS DESIGNED FOR THE STRIKE PLATE RESULTING IN A NEW DESIGN VERSION WITH CAT# 13200110. THE FOUND DRILL MARKS WITHIN THE PROXIMAL AND DISTAL NAIL HOLES INDICATE THAT RADIAL PRESSURE WAS BROUGHT TO THE DRILLS DURING OPERATING (USER ERROR). A FUNCTIONAL TEST REVEALED THAT THE TARGET DEVICE, NAIL HOLDING SCREW AND NAIL WERE FULLY FUNCTIONAL; NO DRILL CONTACT WAS DETECTED WITHIN THE NAIL HOLES. NO NON-CONFORMITY IDENTIFIED.

    Description of Event or Problem · 1

    DURING G3 NAIL SURGERY, WHEN REMOVING THE TARGETING ARM FROM G3 NAIL, THE FIXATION BOLT COULD NOT LOOSE FROM THE DEVICE. THEREFORE THE SURGEON REMOVED THE TARGETING ARM AND G3 NAIL. HE TRIED TO REMOVE THE TARGETING ARM AND G3 NAIL, BUT A SURGEON COULDN'T REMOVE. THE SURGEON USED REPLACEMENT PRODUCT. WHEN INSERTING NAIL, THE SURGEON HIT A JOINT OF NAIL AND DEVICE.

    Description of Event or Problem · 1

    DURING G3 NAIL SURGERY, WHEN REMOVING THE TARGETING ARM FROM G3 NAIL, THE FIXATION BOLT COULD NOT LOOSE FROM THE DEVICE. THEREFORE THE SURGEON REMOVED THE TARGETING ARM AND G3 NAIL. HE TRIED TO REMOVE THE TARGETING ARM AND G3 NAIL, BUT A SURGEON COULDN'T REMOVE. THE SURGEON USED REPLACEMENT PRODUCT. WHEN INSERTING NAIL, THE SURGEON HIT A JOINT OF NAIL AND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834896 NAIL HOLDING SCREW GAMMA3® 8X35MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K740175

    Patients

    Seq Age Sex Outcome Treatment
    1 Other