BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION ROD, CONICAL T2 HUMERUS

    MDR report key: 5343269 · Received January 5, 2016

    Report

    Report Number
    0009610622-2016-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2016
    Date of Event
    December 8, 2015
    Report Date
    December 9, 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

    NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. NO DEVIATION FOUND IN MANUFACTURING OR IN MATERIAL DURING INVESTIGATION. AS THE DEVICE HAD BEEN IN USE FOR YEARS WE PRE-SUPPOSE THAT THEY HAD FULFILLED THEIR TASKS IN FORMER SURGERIES AS INTENDED. THE PARTIALLY DAMAGED THREADS INDICATED THAT THE INSTRUMENT HAD BEEN IN FREQUENT USE, MOST LIKELY INSERTED IN OBLIQUE MODE AND CROSS THREADED. THE AFFECTED ITEM WAS MANUFACTURED IN DECEMBER 2003 IN A TOTAL QUANTITY OF 30 PCS. WHEREOF (B)(4) RECEIVED 13 UNITS (4 IN FEBRUARY 2004, 10 IN THE END 2003/BEGINNING 2004). THEY WERE MANUFACTURED IN ACCORDANCE TO REVISION 1. THE ITEM IN QUESTION HAD BEEN IN USE FOR AT LEAST 11 YEARS IN FREQUENT MANNER. OBLIQUE INSERTION AND ROUGH HANDLING COULD NOT BE EXCLUDED. WEAR IS A TYPICAL RESULT OF USE AND IS POINTED OUT IN IFU AND CLEANING INSTRUCTIONS. REPORTED DELAY IN SURGERY MAY HAVE BEEN CAUSED BY THE ATTEMPTS TO SHAVED BONE AROUND IN ORDER TO RELEASE THE NAIL FROM THE BONE ¿ PERFORMED BECAUSE THE SURGEON HAD ASSUMED THE SURGEON THOUGHT THE NAIL HAD ADHERED TO THE BONE ¿ AND BY REMOVING THE EXTRACTION ROD AND SWITCHING TO ANOTHER INSTRUMENT AS THE NAMED UNIVERSAL ROD. FROM TECHNICAL POINT OF VIEW A FURTHER STATEMENT WAS NOT POSSIBLE. IN CASE FURTHER INFORMATION SHOULD BECOME AVAILABLE, WE RESERVE THE RIGHT TO UPDATE THE INVESTIGATION AND CHANGE THE ROOT CAUSE. THE EVENT WAS NOT CAUSED BY A DEFICIENCY OF THE DEVICE. INSERTION IN AN OBLIQUE MODE IS CLASSIFIED AS USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SR'S INCOMPLETE EXPLANATION, DR. USED AN EXTRACTION ROD (1806-0353) TO REMOVE T2PH SHORT. THERE WERE TWO SURGERIES DONE IN THAT DAY. AT FIRST OPERATION, DR. COULD REMOVE THE NAIL. HOWEVER AT SECOND OPERATION, A ROD COULDN'T FIT TO A NAIL. DR. CONFIRMED TWO RODS (LOT KSS146316 AND K784564). THOUGH A CATALOG NUMBER ARE THE SAME, THESE TWO ROD SHAPES WERE DIFFERENT. AT SECOND OPERATION, DR. USED UNIVERSAL ROD TO REMOVE THE NAIL. DR. DONE EXCESS BONE CUTTING FOR INSERTION OF A K-WIRE. THE SECOND OPERATION EXTENDED ONE HOUR. ADDITIONAL INFORMATION RECEIVED ABOUT THE BONE CUTTING, INDICATED THAT THE AMOUNT WAS A LITTLE. DR. SHAVED BONE AROUND NAIL BY K-WIRE, THICKNESS OF THE SHAVED BONE WAS SAME AS K-WIRE'S DIAMETER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SR'S INCOMPLETE EXPLANATION, DR. USED AN EXTRACTION ROD (1806-0353) TO REMOVE T2PH SHORT. THERE WERE TWO SURGERIES DONE IN THAT DAY. AT FIRST OPERATION, DR. COULD REMOVE THE NAIL. HOWEVER AT SECOND OPERATION, A ROD COULDN'T FIT TO A NAIL. DR. CONFIRMED TWO RODS (LOT KSS146316 AND K784564). THOUGH A CATALOG NUMBER ARE THE SAME, THESE TWO ROD SHAPES WERE DIFFERENT. AT SECOND OPERATION, DR. USED UNIVERSAL ROD TO REMOVE THE NAIL. DR. DID EXCESS BONE CUTTING FOR INSERTION OF A K-WIRE. THE SECOND OPERATION EXTENDED ONE HOUR. ADDITIONAL INFORMATION RECEIVED ABOUT THE BONE CUTTING, INDICATED THAT THE AMOUNT WAS A LITTLE. DR. SHAVED BONE AROUND NAIL BY K-WIRE, THICKNESS OF THE SHAVED BONE WAS SAME AS K-WIRE'S DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3239 EXTRACTION ROD, CONICAL T2 HUMERUS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K784564

    Patients

    Seq Age Sex Outcome Treatment
    1 Other