BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-05151

    MDR report key: 3310924 · Received August 27, 2013

    Report

    Report Number
    2520274-2013-05151
    Event Type
    Injury
    Date Received
    August 27, 2013
    Report Date
    July 31, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS EVENT DATE: (B)(6) 2012; 98(3):288-295. THIS PATIENT EXPERIENCED EARLY SURGICAL-SITE INFECTION REQUIRING REOPERATION FOR SURGICAL SITE LAVAGE WITH INTRAOPERATIVE COLLECTION OF MULTIPLE BACTERIOLOGICAL SPECIMENS. NO MICROORGANISM WAS RECOVERED, NO ANTIBIOTICS WERE GIVEN AND NO RECURRENT INFECTION HAD OCCURRED AT LAST FOLLOW-UP. THIS REPORT IS ON AN UNKNOWN BLADE. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    JOURNAL ARTICLE RECEIVED: PROXIMAL FEMORAL NAIL ANTIROTATION (PFN-ATM) FIXATION OF EXTRA-CAPSULAR PROXIMAL FEMORAL FRACTURES IN THE ELDERLY: RETROSPECTIVE STUDY IN 102 PATIENTS; ORTHOPAEDICS AND TRAUMATOLOGY: SURGERY AND RESEARCH; 2012 MAY; 98(3): 288-295. AUTHORS: E. SOUCANYE DE LANDEVOISIN, A. BERTANI, P. CANDONI, C. CHARPAIL, E. DEMORTIERE. THIS STUDY COVERED 102 FRACTURES MANAGED WITH PFN-A IN ALL 102 PATIENTS. THE MEAN AGE WAS 84.9 +/- 9.5 YEARS WITH 75 FEMALES AND 27 MALES. ALL PATIENTS WERE IMPLANTED WITH THE 200MM NAIL/10MM DIAMETER AND AN ANGLE OF 125 DEGREES. THERE WERE 12 POSTOPERATIVE SURGICAL COMPLICATIONS INCLUDING TWO SURGICAL SITE INFECTIONS, 3 INSTANCES OF BLADE CUT-OUT INCLUDING ONE WITH ACETABULAR PENETRATION, 2 NAIL-RELATED FRACTURES AND FIVE BLADE BACK-OUTS RESPONSIBLE FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420830 HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention