BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HOLDING SCREW GAMMA3 8X35MM

    MDR report key: 3244160 · Received July 24, 2013

    Report

    Report Number
    0009610622-2013-00412
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    EVALUATION CONCLUSION: THE REPORTED ISSUE WAS NOT CONFIRMED. EVALUATION REVEALED THE NHS WITH LOT CODE K198437 TO BE THE PRIMARY PRODUCT. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICE HAD BEEN IN USE FOR APPROX. ONE YEAR WE PRE-SUPPOSE THAT IT HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. FURTHERMORE THE CUSTOMER REPORTED THAT THE DEVICES WERE CONSIGNMENT AND USED FOR MANY TIMES. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. RESTS OF BODY LIQUIDS AND SMALL FRETTING MARKS ARE VISIBLE ON THE LOWER SIDE OF THE NHS HEAD; HERE IT HAD CONTACT TO THE NAIL ADAPTER OF THE TARGET DEVICE. IT IS POSSIBLE THAT BODY LIQUIDS AND BONE MATERIAL BLOCK THE NHS AND CAUSED THE JAMMING. FURTHERMORE IT IS POSSIBLE THAT THE FOUND FRETTING MARKS DID CONTRIBUTE TO THE BLOCKED NHS. FRETTING MARKS ARE A RARE BUT KNOWN REACTION. DURING SCREWING INTO THE NAIL THE NHS GETS IN CONTACT WITH THE METAL NAIL ADAPTER AND FRICTION COULD OCCUR DUE TO TOO HIGH TORQUE FORCES (USER RELATED). IN COMBINATION WITH SMALL TOLERANCES IT IS POSSIBLE THAT COLD WELDING OCCURS. HOWEVER, BECAUSE NO DEVIATIONS WERE FOUND IN THE DIMENSIONS, MATERIAL, DESIGN AND MANUFACTURING PROCESS AND THE REPORTED ISSUE WAS NOT REPRODUCIBLE A MANUFACTURING ISSUE COULD BE EXCLUDED. THEREFORE THE CASE IS ATTRIBUTED TO AN INADEQUATE USAGE. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO ACTIONS ARE IN PLACE.

    Description of Event or Problem · 1

    WE IMPLANTED THE ROD, PUT THE LAG SCREW AND DISTAL SCREW IN. ONCE EVERYTHING WAS IMPLANTED AND ATTEMPTED TO DISENGAGE THE OUTRIGGER TO THE IMPLANT, IT WOULD NOT RELEASE. THE DOCTOR TRIED WITH ALL OF HIS STRENGTH BUT COULD NOT GET IT RELEASED. THE DISTAL LOCKING SCREW AND LAG SCREW HAD TO BE REMOVED AS WELL AS THE ROD. EVEN AFTER REMOVING THE CONSTRUCT FROM THE PATIENT, THE ROD STILL COULD NOT BE SEPARATED FROM THE INSTRUMENT. THEY BEGAN TO MALLET AND HAD TO FORCIBLY REMOVE THE ROD FROM THE INSTRUMENT. THE SECOND IMPLANTATION ATTEMPT WAS SUCCESSFUL.

    Description of Event or Problem · 1

    WE IMPLANTED THE ROD, PUT THE LAG SCREW AND DISTAL SCREW IN. ONCE EVERYTHING WAS IMPLANTED AND ATTEMPTED TO DISENGAGE THE OUTRIGGER TO THE IMPLANT, IT WOULD NOT RELEASE. THE DOCTOR TRIED WITH ALL OF HIS STRENGTH BUT COULD NOT GET IT RELEASED. THE DISTAL LOCKING SCREW AND LAG SCREW HAD TO BE REMOVED AS WELL AS THE ROD. EVEN AFTER REMOVING THE CONSTRUCT FROM THE PATIENT, THE ROD STILL COULD NOT BE SEPARATED FROM THE INSTRUMENT. THEY BEGAN TO MALLET AND HAD TO FORCIBLY REMOVE THE ROD FROM THE INSTRUMENT. THE SECOND IMPLANTATION ATTEMPT WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347065 NAIL HOLDING SCREW GAMMA3 8X35MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K198437

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other