BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-05268

    MDR report key: 3330381 · Received September 6, 2013

    Report

    Report Number
    2520274-2013-05268
    Event Type
    Injury
    Date Received
    September 6, 2013
    Report Date
    August 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MEAN AGE: 78.1 YEARS; 74.2% WOMAN: 25.8% MEN. DATE OF EVENT: 2003. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. FROM FFN TO PFN.

    Description of Event or Problem · 1

    JOURNAL ARTICLE RECEIVED: INTRAMEDULLARY FIXATION OF INTERTROCHANTERIC FRACTURES WITH THE PROXIMAL FEMORAL NAIL (PFN). ORTHOP TRAUMATOL, 2003: 15: 20-37.: AUTHORS: AKHIL P. VERHEYDEN AND CHRISTOPH JOSTEN. THIS ARTICLE DOES MENTION SYNTHES DEVICES, PLEASE SEE ATTACHED ARTICLE. THIS STUDY WAS DONE BETWEEN (B)(6) 1996 AND (B)(6) 1999 WITH 231 PATIENTS IMPLANTED WITH THE FFN SYSTEM. THE STUDY SHOWS THE TECHNIQUE USED, INTRA- OPERATIVE AND POST-OPERATIVE COMPLICATIONS, AND LATE COMPLICATIONS. INTRO-OPERATIVE COMPLICATIONS: THREE INADEQUATE REDUCTIONS RESULTING IN A REVISION: ONE ANTIROTATION SCREW WAS INSERTED TOO DEEP REQUIRING REMOVAL THROUGH THE FRACTURE GAP. POST-OPERATIVE COMPLICATIONS REPORTED: TWELVE PATIENTS DIED WHILE IN THE HOSPITAL: ONE FEMORAL FRACTURE; OSTEOPOROTIC BEDRIDDEN PATIENT FELL OUT OF BED: THREE PATIENTS THE IMPLANT BROKE; CAUSE IN ALL 3 WAS INADEQUATE REDUCTION AND SUBOPTIMAL PLACEMENT OF THE NECK SCREW IN THE NECK/HEAD FRAGMENT: 14 PATIENTS DEVELOPED A HEMATOMA OR SEROMA; IF THE SONOGRAPHICALLY CONFIRMED THICKNESS OF THE FLUID COLLECTION EXCEEDED 1 CM, A REVISION WAS DONE: THREE DEEP INFECTIONS; HEALED AFTER IMPLANT REMOVAL: ONE DEEP INFECTION WITH LOOSENING REQUIRING A GIRDLESTONE PROCEDURE. LATE COMPLICATIONS REPORTED: NINE PATIENTS THE ANTIROTATION SCREW MIGRATED; 8 TIMES BACKING OUT LATERALLY,1 MIGRATING MEDIALLY ONTO THE JOINT: 2 CASES OF LATE ABSCESS FORMATION. THIS COMPLAINT IS ON THE POST-OPERATIVE; 3 PATIENTS THE IMPLANT BROKE; CAUSE IN ALL 3 WAS INADEQUATE REDUCTION AND SUBOPTIMAL PLACEMENT OF THE NECK SCREW IN THE NECK/HEAD FRAGMENT.(UNKNOWN SCREW) THIS IS 3 OF 3 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444391 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention