BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL NAIL, AP T2 HUMERUS Ø7X240 MM

    MDR report key: 3982409 · Received August 6, 2014

    Report

    Report Number
    0009610622-2014-00387
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 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: PRODUCT INQUIRY STATES THE HUMERAL NAIL T2 TO BE THE SUBJECT PRODUCT. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED NO DISCREPANCIES. THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DIMENSIONAL INSPECTION OF THE NAIL IN THE NON-DAMAGED AREAS REVEALED NO DEVIATION. WITH RESPECT TO THE APPEARANCE OF DAMAGE FOUND AND ACCORDING TO THE REPRODUCTION OF THE SCENARIO WITH THE NAIL RETURNED AND SAMPLE DEVICES IT APPEARS BEING UTMOST LIKELY THAT THE NAIL HOLDING SCREW WAS NOT SUFFICIENTLY TIGHTENED DURING ROTATING THE TARGET DEVICE IN ORDER TO ADVANCE THE NAIL TO ITS DESIRED POSITION. IF THE NAIL HOLDING SCREW IS NOT PROPERLY TIGHTENED, A POSITIVE (FRICTIONAL) CONNECTION BETWEEN NAIL AND NAIL ADAPTER CANNOT BE ACHIEVED SO THAT THE SHOWN DAMAGE MAY OCCUR. REATTACHMENT OF THE TARGET DEVICE TO THE NAIL AFTER INSERTING THE COMPRESSION SCREW IS DESCRIBED IN DETAIL IN THE ¿T² HUMERAL NAILING SYSTEM OP-TECHNIQUE¿ (B1000006) IN CHAPTER ADVANCED LOCKING MODE. BASED ON THE ABOVE OBSERVATIONS THE ROOT CAUSE OF THE REPORTED EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICE BUT IS RATHER USER RELATED TO NON INTENDED USE (DEVIATION FROM SURGICAL TECHNIQUE). NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT CLEARED FOR SALE IN THE US BUT A SIMILAR DEVICE IS.ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING T2 HUMERAL NAIL SURGERY, THE SURGEON INSERTED THE NAIL TO THE PATIENT BONE. ALONG THE WAY, THE SURGEON REMOVED DEVICE FROM THE NAIL AND INSERTED THE COMPRESSION SCREW INTO THE NAIL. THE SURGEON ASSEMBLED THE NAIL WITH THE DEVICE AGAIN AFTER INSERTING THE COMPRESSION SCREW. BECAUSE THE DEVICE WAS UNSTABLE WHEN THE SURGEON CHECKED IT WAS DETERMINED THAT THE PROXIMAL PART OF THE NAIL WAS DEFORMED. THEREFORE THE SURGEON CHANGED THE NAIL TO BRAND NEW NAIL.

    Description of Event or Problem · 1

    DURING T2 HUMERAL NAIL SURGERY, THE SURGEON INSERTED THE NAIL TO THE PATIENT BONE. ALONG THE WAY, THE SURGEON REMOVED DEVICE FROM THE NAIL AND INSERTED THE COMPRESSION SCREW INTO THE NAIL. THE SURGEON ASSEMBLED THE NAIL WITH THE DEVICE AGAIN AFTER INSERTING THE COMPRESSION SCREW. BECAUSE THE DEVICE WAS UNSTABLE WHEN THE SURGEON CHECKED IT WAS DETERMINED THAT THE PROXIMAL PART OF THE NAIL WAS DEFORMED. THEREFORE THE SURGEON CHANGED THE NAIL TO BRAND NEW NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460822 HUMERAL NAIL, AP T2 HUMERUS Ø7X240 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K285618

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other