BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 3715873 · Received March 31, 2014

    Report

    Report Number
    2520274-2014-10529
    Event Type
    Injury
    Date Received
    March 31, 2014
    Report Date
    March 25, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. TREATMENT OF PATHOLOGICAL HUMERUS SHAFT FRACTURES WITH INTRAMEDULLARY NAILS WITH OR WITHOUT CEMENT FIXATION; LAITINEN,M, NIEMINEN,J, PAKARINEN,T-K; ARCH ORTHOP TRAUMA SURG (2011) 131:503¿508. THIS REPORT IS FOR ONE UNKNOWN HUMERAL NAIL. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT 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 JOURNAL ARTICLE: TREATMENT OF PATHOLOGICAL HUMERUS SHAFT FRACTURES WITH INTRAMEDULLARY NAILS WITH OR WITHOUT CEMENT FIXATION; LAITINEN,M, NIEMINEN,J, PAKARINEN,T-K; ARCH ORTHOP TRAUMA SURG (2011) 131:503¿508. THIS IS A RETROSPECTIVE CONTROL STUDY OF 21 PATIENTS WHO UNDERWENT CEMENTED INTRAMEDULLARY NAILING FOR PATHOLOGICAL FRACTURES IN THE HUMERAL SHAFT BETWEEN 2005 AND 2009 AS COMPARED TO A HISTORICAL CONTROL GROUP OF 19 PATIENTS THAT UNDERWENT LOCKED INTRAMEDULLARY NAILING FOR PATHOLOGICAL FRACTURES IN THE HUMERAL SHAFT BETWEEN 1999 AND 2004. FOUR MAJOR OUTCOMES WERE ASSESSED, NAMELY PAIN RELIEF, USE OF ANALGESICS, RECOVERY OF FUNCTION AND RATE OF COMPLICATION. PATIENTS TREATED WITH CEMENTED INTRAMEDULLARY NAILING HAD BETTER PAIN RELIEF, LESS USE OF ANALGESICS AND BETTER FUNCTIONAL RESTORATION IMMEDIATELY AFTER SURGICAL PROCEDURE WHEN COMPARED TO THE PATIENTS WITHOUT CEMENT FIXING. THE RATE OF COMPLICATION DID NOT DIFFER BETWEEN THESE TWO GROUPS. A RETROSPECTIVE CASE CONTROL STUDY WAS PERFORMED TO ASSESS THE USE OF DIFFERENT FIXATION METHODS OF INTRAMEDULLARY NAILING ON FUNCTIONAL OUTCOME AS WELL AS ON PAIN RELIEF AND USAGE OF ANALGESICS. ALL PATIENTS ADMITTED BETWEEN 1999 AND 2004 WERE TREATED WITH LOCKING INTRAMEDULLARY NAIL WITHOUT CEMENT FIXATION USING THE UNIVERSAL HUMERAL NAIL (UHN) FROM SYNTHES. THOSE PATIENTS ADMITTED BETWEEN 2005 AND 2009 WERE ALL TREATED WITH CEMENTED INTRAMEDULLARY UHN NAIL WITHOUT LOCKING SCREWS. THERE WERE NO MAJOR HARDWARE COMPLICATIONS IN EITHER GROUP. IN THE NON-CEMENTED GROUP THERE WERE TWO SUPERFICIAL INFECTIONS WHICH WERE TREATED SUCCESSFULLY WITH PER-ORAL ANTIBIOTICS AND ONE DEEP-INFECTION, WHICH WAS ALSO TREATED WITH PER-ORAL ANTIBIOTICS BECAUSE THE OVERALL HEALTH STATUS OF THE PATIENT WAS POOR. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187195 NAIL, FIXATION, BONE JDS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention