BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 5815304 · Received July 22, 2016

    Report

    Report Number
    2520274-2016-13596
    Event Type
    Injury
    Date Received
    July 22, 2016
    Report Date
    July 7, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS TIP-APEX DISTANCE AS A PREDICTOR OF FAILURE FOLLOWING CEPHALO-MEDULLARY FIXATION FOR UNSTABLE FRACTURES OF THE PROXIMAL FEMUR WALTON. J, BARNETT, A., AND JACKSON. M. EUROPEAN JOURNAL OF TRAUMA AND EMERGENCY SURGERY 2008 : 34:273-276. THIS IS FOR A UNKNOWN PROXIMAL FIXATION NAIL. (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. 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. 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ABSTRACT. TIP-APEX DISTANCE AS A PREDICTOR OF FAILURE FOLLOWING CEPHALO-MEDULLARY FIXATION FOR UNSTABLE FRACTURES OF THE PROXIMAL FEMUR WALTON. J, BARNETT, A., AND JACKSON. M. EUROPEAN JOURNAL OF TRAUMA AND EMERGENCY SURGERY 2008 : 34:273-276 UNITED KINGDOM. A RETROSPECTIVE ANALYSIS OF THE OUTCOME OF PROXIMAL FEMORAL FRACTURES TREATED WITH THE PROXIMAL FEMORAL NAIL (PFN, SYNTHES) WITH PARTICULAR REFERENCE TO IMPLANT POSITION AND ADEQUACY OF REDUCTION. BETWEEN MAY 2002 AND OCTOBER 2004, 61 PATIENTS WITH LOW-ENERGY UNSTABLE PROXIMAL FEMORAL FRACTURES UNDERWENT SURGERY AT A MEAN 2.4 DAYS. MEAN AGE WAS 78 YEARS, 45 FEMALE AND 16 MALE PATIENTS. FOUR PATIENTS REQUIRED FURTHER SURGERY PRIOR TO THE DEVELOPMENT OF RADIOLOGICAL UNION. ONE PATENT REQUIRED SECONDARY STABILIZATION WITH CIRCLAGE WIRING AT 7 WEEKS FOLLOWING THE INITIAL OPERATION, DUE TO FRACTURE DISPLACEMENT. ONE PATIENT HAD BACKING OUT OF THE PROXIMAL DE-ROTATION SCREW FOLLOWING RADIOLOGICAL UNION, NECESSITATING REMOVAL. TWO PATIENTS HAD DELAYED UNION BUT UNITED FOLLOWING DYNAMIZATION BY REMOVAL OF DISTAL LOCKING BOLTS. THIS IS REPORT # OF # FOR (B)(4). THIS REPORT IS FOR A PROXIMAL FEMUR NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470269 NAIL, FIXATION, BONE JDW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention