BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD,FIXATION,INTRAMEDULLARY

    MDR report key: 5830272 · Received July 28, 2016

    Report

    Report Number
    2520274-2016-13697
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Report Date
    July 7, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "PROXIMAL FEMORAL NAIL ANTIROTATION (PFN-ATM) FIXATION OF EXTRA-CAPSULAR PROXIMAL FEMORAL FRACTURES IN THE ELDERLY: RETROSPECTIVE STUDY IN 102 FRACTURES MANAGED WITH PFN-A PATIENTS"(2012) DE LANDEVOISIN, E. S., BERTANI, A., CANDONI, P., CHARPAIL , C., AND DEMORTIERE, E. ORTHOPAEDICS AND TRAUMATOLOGY: SURGERY AND RESEARCH, 98, 288-295. THIS REPORT IS FOR AN UNKNOWN PROXIMAL FEMORAL NAIL ANTIROTATION/UNKNOWN QUANTITY/UNKNOWN LOT. 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. 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 COMPLAINT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: DE LANDEVOISIN, E. S., BERTANI, A., CANDONI, P., CHARPAIL , C., AND DEMORTIERE, E. (2012) PROXIMAL FEMORAL NAIL ANTIROTATION (PFN-A) FIXATION OF EXTRA-CAPSULAR PROXIMAL FEMORAL FRACTURES IN THE ELDERLY: RETROSPECTIVE STUDY IN 102 FRACTURES MANAGED WITH PFN-A PATIENTS. ORTHOPAEDICS AND TRAUMATOLOGY: SURGERY AND RESEARCH, 98, 288-295. FRANCE. A SINGLE CENTER RETROSPECTIVE STUDY REVIEWED PATIENTS THAT UNDERWENT PROXIMAL FEMORAL NAIL ANTIROTATION (PFN-A) (SYNTHES, (B)(4)) IMPLANTATION FOR FIXATION, PERFORMED BETWEEN 2006 AND 2008 IN 102 PATIENTS (75 FEMALES AND 27 MALES) WITH A MEAN AGE 84.9 YEARS OF AGE. TWO PATIENTS EXPERIENCED BLADE BACK OUT. TWO PATIENTS EXPERIENCED BLADE MALPOSITION. TWO PATIENTS EXPERIENCED CEPHALIC BLADE CUT OUTS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PFN-A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481503 ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1