BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01773

    MDR report key: 3030328 · Received April 2, 2013

    Report

    Report Number
    2520274-2013-01773
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS COULD NOT BE CHECKED FOR ITS SPECIFICATION AS THE ARTICLE AND LOT NUMBER HAVE NOT BEEN PROVIDED. UNFORTUNATELY ALSO THE SAME APPLIES FOR THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPER. THE INVESTIGATION SHOWS NO IRREGULARITIES. UNFORTUNATELY THE INFORMATION GIVEN DID NOT PROVIDE SUFFICIENT EVIDENCE FOR AN EXACT DETERMINATION OF THE FAILURE REASON. WE DO SUPPOSE AS MENTIONED THAT EARLY FULL WEIGHT BEARING WAS DONE BY THE PATIENT WHICH RESULTED IN THE BREAKAGE OF THE SCREWS.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE IS POSSIBLE 2.4MM VA LOCKING SCREW. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DEVICE WAS RECEIVED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THIS REPORT IS #1 OF 4 FOR THE SAME EVENT REPORTED UNDER COMPLAINT (B)(4).

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A HOSPITAL IN THE (B)(6) REPORTED: PATIENT WAS IMPLANTED WITH PLATE AND VA LOCKING SCREWS FOR HALLUX VALGUS ON AN UNKNOWN DATE. IT WAS NOTED: EARLY FULL WEIGHT BEARING DONE BY THE PATIENT LED TO A BROKEN 2.4MM VA LOCKING SCREW. PATIENT WAS RETURNED TO THE OR, DATE UNKNOWN, AND SURGEON REMOVED THE BROKEN HARDWARE SUCCESSFULLY. THIS IS 1 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133629 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention