BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_KIE_PRODUCT

    MDR report key: 4918206 · Received July 16, 2015

    Report

    Report Number
    0009610622-2015-00350
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 19, 2015
    Manufacturer
    STRYKER TRAUMA KIEL (MDR)
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN NAIL. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: PRODUCT INQUIRY STATED AN UNKNOWN GAMMA AP-J NAIL AND AN UNKNOWN DISTAL LOCKING SCREW TO BE THE SUBJECT PRODUCTS. THE UNKNOWN LAG SCREW WAS CONSIDERED TO BE A CONCOMITANT ITEM AS IT DID NOT CONTRIBUTE TO THE EVENT REPORTED. A PHYSICAL EXAMINATION COULD NOT BE CARRIED OUT AS THE DEVICES WERE NOT RETURNED TO STRYKER KIEL. A REVIEW OF THE DEVICE HISTORY COULD NOT BE CARRIED OUT AS THE LOT CODES WERE UNKNOWN. THUS, A REASONABLE EXAMINATION AND INVESTIGATION WAS NOT POSSIBLE. REFERRING TO THE EVENT DESCRIPTION THE PATIENT HAD BEEN TREATED WITH AN UNKNOWN GAMMA NAIL ABOUT 10 YEARS AGO. IT WAS FURTHER STATED THAT THE ATTENDING PHYSICIAN FOUND ¿THAT THE FRACTURE PART WAS BONE NON-UNION¿. AND THE SURGEON FOUND THAT ¿THE NAIL (LAG SCREW HOLE) AND DISTAL SCREW WERE BROKEN¿. FURTHER INFORMATION SUCH AS X-RAYS, MEDICAL RECORDS, PRODUCT- / PATIENT DATA AND OP REPORTS WERE NOT AVAILABLE. A NAIL WILL BE SUBJECT OF A FATIGUE FRACTURE IF THE BIOMECHANICAL STRESSES ON THE IMPLANT ARE TOO HIGH OR NOT CONSIDERABLY REDUCED DURING THE PERIOD OF IMPLANTATION. DURING THIS PERIOD THERE IS A RACE BETWEEN BONY CONSOLIDATION / FRACTURE HEALING AND IMPLANT BREAKAGE. USUALLY A BREAKAGE IS CONTRIBUTED BY ONE OR MORE DEFICITS, E.G. INSUFFICIENT BONE HEALING, PRODUCT DAMAGE. IN THIS CASE, REFERRING TO RECEIVED INFORMATION, THE NAIL AND THE SCREW HAD BEEN IMPLANTED FOR OVER 10 YEARS. FURTHERMORE A NON-UNION WAS CONFIRMED BY THE ATTENDING PHYSICIAN. NEVERTHELESS THE REPORTED EVENT (¿NAIL AND DISTAL SCREW WERE BROKEN¿) COULD NOT BE CONFIRMED, SINCE THE DEVICES WERE NOT RETURNED FOR EVALUATION NOR WERE ANY X-RAYS PROVIDED SHOWING A NAIL OR SCREW BREAKAGE. IMPLANT BREAKAGE MAY OCCUR WHEN THE MATERIAL IS SUBJECTED TO REPEATED LOADING AND UNLOADING RESULTING FATIGUE OF MATERIAL. IF THE LOADS ARE ABOVE A CERTAIN THRESHOLD (MICROSCOPIC) CRACKS WILL BEGIN TO FORM ON THE SURFACE. A REQUIREMENT FOR SUCCESSFUL TREATMENT WITH AN INTRAMEDULLARY NAIL IS THAT BONE HEALING DEVELOPS IN A SUFFICIENT MANNER THAT THE IMPLANT IS RELIEVED BY LOAD SHARING / LOAD TRANSMISSION OVER THE BONE. OTHERWISE THE IMPLANT MAY BE SUBJECT TO A FATIGUE FRACTURE. FURTHER INFORMATION REGARDING THE EVENT COULD NOT BE PROVIDED. NO FURTHER TECHNICAL STATEMENT WAS POSSIBLE. AS TO MISSING MEDICAL RECORDS NO MEDICAL STATEMENT WAS POSSIBLE. WITH AVAILABLE INFORMATION A DEFICIENCY OF THE NAIL AND OF THE SCREW COULD NOT BE VERIFIED. BASED ON THE CONFIRMED NON-UNION AND ON THE FACT THAT THE NAIL HAD BEEN IMPLANTED FOR OVER 10 YEARS, IT IS VERY LIKELY THAT THE NAIL AND THE SCREW BROKE IN A FATIGUE FRACTURE. NEVERTHELESS AS THE ITEMS COULD NOT BE EXAMINED, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE FILE WILL BE CLOSED FORMALLY. IN CASE RELEVANT CLINICAL INFORMATION SHOULD BECOME AVAILABLE, WE RESERVE THE RIGHT TO UPDATE THE INVESTIGATION AND CHANGE THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT 10 YEARS BEFORE, THE PATIENT UNDERWENT THE SURGERY WITH THE AP-J NAIL FOR TROCHANTER FRACTURE. THE PATIENT FELT THE PAIN IN THE HIP. THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE FRACTURE PART WAS BONE NON-UNION. AND THE SURGEON FOUND THAT THE NAIL(LAG SCREW HOLE) AND DISTAL SCREW WERE BROKEN. THEREFORE THE SURGEON EXTRACTED THE IMPLANTS ON (B)(6) 2015. THE SURGEON IS PLANNING THE REVISION SURGERY BY BHP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT 10 YEARS BEFORE, THE PATIENT UNDERWENT THE SURGERY WITH THE AP-J NAIL FOR TROCHANTER FRACTURE. THE PATIENT FELT THE PAIN IN THE HIP. THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE FRACTURE PART WAS BONE NON-UNION. AND THE SURGEON FOUND THAT THE NAIL(LAG SCREW HOLE) AND DISTAL SCREW WERE BROKEN. THEREFORE THE SURGEON EXTRACTED THE IMPLANTS ON (B)(6) 2015. THE SURGEON IS PLANNING THE REVISION SURGERY BY BHP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461704 UNKNOWN_KIE_PRODUCT IMPLANT HSB STRYKER TRAUMA KIEL (MDR) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention