BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3916953 · Received July 7, 2014

    Report

    Report Number
    2520274-2014-11915
    Event Type
    Injury
    Date Received
    July 7, 2014
    Report Date
    June 12, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT FOR DIAGNOSIS. GARRIGUES, G., (2011), FIXATION OF THE CORONOID PROCESS IN ELBOW FRACTURE-DISLOCATION, JOURNAL OF BONE AND JOINT SURGERY, 93, 1873-1881. THIS REPORT IS FOR AN UNKNOWN SCREW. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: GARRIGUES, G., (2011), FIXATION OF THE CORONOID PROCESS IN ELBOW FRACTURE-DISLOCATION, JOURNAL OF BONE AND JOINT SURGERY, 93, 1873-1881. A RETROSPECTIVE CHART REVIEW PERFORMED AT THREE TERTIARY CARE CENTERS IDENTIFIED FORTY CONSECUTIVE PATIENTS TREATED FOR TERRIBLE TRIAD INJURIES OF THE ELBOW WITH A MINIMUM FOLLOW-UP OF EIGHTEEN MONTHS. ALL PATIENTS WERE MANAGED WITH A STANDARD APPROACH CONSISTING OF: (1) REPAIR OR REPLACEMENT OF THE RADIAL HEAD; (2) REPAIR OF THE LATERAL ULNAR COLLATERAL LIGAMENT OF THE ELBOW; AND (3) REPAIR OF THE CORONOID FRACTURE WITH ONE OF TWO TECHNIQUES: GROUP I (N = 28) CONSISTED OF THE ¿LASSO¿ TECHNIQUE AND GROUP II (N = 12) CONSISTED OF OPEN REDUCTION AND INTERNAL FIXATION WITH SCREWS OR SUTURE ANCHORS. WITHIN GROUP II, FIVE PATIENTS RECEIVED EITHER A 3.0 OR 3.5MM PARTIALLY-THREADED CANNULATED CORTICAL SCREW. THREE OF THE FIVE ELBOWS IN WHICH SCREWS WERE USED HAD IMPLANT FAILURE. IN THE TWO OTHER ELBOWS, FAILED FIXATION LED TO GAPPING AND NONUNION OF THE CORONOID. ONE OF THESE PATIENTS DEVELOPED ARTHROSIS AND REQUIRED A TOTAL ELBOW ARTHROPLASTY. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT INVOLVES AN UNKNOWN SCREW FOR DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394034 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention