BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 5701221 · Received June 6, 2016

    Report

    Report Number
    2520274-2016-12973
    Event Type
    Injury
    Date Received
    June 6, 2016
    Report Date
    May 22, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    HUI, C., JORGENSEN, I., BUCKLEY, R., AND FICK, G. (2007). INCIDENCE OF INTRAMEDULLARY NAIL REMOVAL AFTER FEMORAL SHAFT FRACTURE HEALING. CAN J SURG. 50(1): PP 13-18. THIS REPORT IS FOR AN UNKNOWN FEMORAL NAIL/UNKNOWN LOT/QUANTITY UNKNOWN. (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, HUI, C., JORGENSEN, I., BUCKLEY, R., AND FICK, G. (2007). INCIDENCE OF INTRAMEDULLARY NAIL REMOVAL AFTER FEMORAL SHAFT FRACTURE HEALING. CAN J SURG. 50(1): PP 13-18. CANADA ARTICLE. THIS STUDY AIMS TO ILLUSTRATE, THROUGH ONE TRAUMA SURGEON'S PRACTICE, THE INCIDENCE OF INTRAMEDULLARY NAIL (IMN) REMOVAL IN HEALED MIDSHAFT FEMORAL FRACTURES. THE IMN USED FOR FEMORAL SHAFT FRACTURES DURING THIS TIME WAS THE SYNTHES TITANIUM LOCKED FEMORAL NAIL. NO NAILS WERE REMOVED WITHOUT PATIENT SYMPTOMATOLOGY. PATIENT SYMPTOMATOLOGY WAS DEFINED AS PAIN OR IRRITATION DIRECTLY RELATED TO THE HARDWARE AND AFFECTING ACTIVITIES OF DAILY LIVING. BETWEEN JULY 1990 AND NOVEMBER 2003, 68 PATIENTS HAD A TOTAL OF 74 LOCKED IMNS INSERTED IN ANTEROGRADE FASHION FOR ACUTE MIDSHAFT FEMORAL FRACTURES IN THIS TRAUMA PRACTICE. (THREE PATIENTS WHO WERE TREATED WITH IMN DIED AND WERE REMOVED FROM THE ANALYSIS BECAUSE THEY WERE NOT SUBJECTED TO THE RISK OF REMOVAL.) OF THESE PATIENTS, 48 WERE MALE AND 20 FEMALE WITH AN AVERAGE AGE OF 29 YEARS. THE OVERALL INCIDENCE OF FEMORAL NAIL REMOVAL AFTER MIDSHAFT FEMORAL FRACTURE HEALING WAS 20% (15 OF 74 FRACTURES). FOURTEEN PATIENTS (7 MALE AND 7 FEMALE) WITH 15 FEMORAL SHAFT FRACTURES UNDERWENT IMN REMOVAL. THE MOST COMMON REASON FOR REMOVAL WAS PERSISTENT FEMORAL PAIN OR IRRITATION. THE OVERALL COMPLICATION RATE WAS 19% (13 OF 68 PATIENTS). SCREW BREAKAGE WAS IDENTIFIED IN FOUR PATIENTS. TWO PATIENTS REQUIRED EXCHANGE NAILING FOR DELAYED UNION. TWO PATIENTS HAD NONFATAL FAT EMBOLISM SYNDROME. ONE PATIENT HAD OSTEOPETROSIS AND DEVELOPED OSTEOMYELITIS, REQUIRING SEVERAL EXCHANGE NAILINGS. MINOR HETEROTOPIC OSSIFICATION WAS SEEN IN ONE PATIENT. TWO PATIENTS HAD THE DISTAL LOCKING SCREWS REMOVED SECONDARY TO HARDWARE PAIN BUT KEPT THE ROD IN PLACE. THE PATIENTS ASSOCIATED WITH THIS ARTICLE WERE TREATED IN CANADA. THIS REPORT IS FOR AN UNKNOWN FEMORAL NAIL. THIS IS REPORT 4 OF 16 FOR (B)(4) AND REFERS TO ONE MALE PATIENT WITH A FEMORAL SHAFT FRACTURES WHO UNDERWENT IMN REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355061 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention