BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5056970 · Received September 4, 2015

    Report

    Report Number
    2520274-2015-15667
    Event Type
    Injury
    Date Received
    September 4, 2015
    Date of Event
    July 22, 2010
    Report Date
    August 27, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THIS REPORT IS FOR 3 UNKNOWN CANNULATED (7.3 MM TITANIUM) SCREWS /UNKNOWN LOT. SECONDARY FRACTURE DISLOCATION. 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 REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE JANSSEN, H; FREY, S.P. AND MEFFERT, R.H. "FEMORAL NECK SCREW FIXATION IN THE ELDERLY". TRAUMA SURGEON, 2011-114, PP.445¿451. A RETROSPECTIVE ANALYSIS WAS CARRIED OUT ON PATIENTS TREATED FOR FEMORAL NECK FRACTURE WITH 3 CANNULATED (7.3 MM TITANIUM) SCREWS FIXATION BETWEEN 4/1/2004 AND 9/30/2009. IN TOTAL, 62 PATIENTS HAVE BEEN TREATED WITH THIS TECHNIQUE. OF THESE, 35 PATIENTS (56%) WERE OLDER THAN 65 YEARS (AVERAGE AGE IS 77.7 YEARS, WITH THE OLDEST PATIENT BEING 106 YEARS). COMPLICATION-SPECIFIC INTERVENTION WAS GIVEN TO 4 PATIENTS: 2 CASES (5.7%) OF A SECONDARY FRACTURE DISLOCATION 4 DAYS AND 6 WEEKS POSTOPERATIVELY, WHICH WERE TREATED WITH HEMIPROSTHESIS. SUBTROCHANTERIC FEMORAL FRACTURE OCCURRED IN 2 CASES. A COPY OF THE LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR 3 UNKNOWN CANNULATED (7.3 MM TITANIUM) SCREWS WHICH REFERS 2 CASES (5.7%) OF A SECONDARY FRACTURE DISLOCATION 4 DAYS AND 6 WEEKS POSTOPERATIVELY, WHICH WERE TREATED WITH HEMIPROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587479 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention