BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-03825

    MDR report key: 3190446 · Received June 26, 2013

    Report

    Report Number
    2520274-2013-03825
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 29, 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

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL INFORMATION FROM SYNTHES (B)(4). INITIAL IMPLANTATION: ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    THE RELEVANT DIMENSIONS COULD NOT BE CHECKED BECAUSE OF THE DAMAGES, WHICH WERE CAUSED DURING THE EXTRACTION. AFTERWARDS IT IS IMPOSSIBLE TO DETERMINE THE EXACT CAUSE OF THE SCREW BLOCKAGE. THE REASON FOR THIS PHENOMENON MAY BE DIFFERENT. IT IS POSSIBLE TOO MUCH APPLIED FORCE WHILE TIGHTENING OR AN IMPROPER ALIGNMENT BETWEEN THE SCREW AND THE PLATE CAN LEAD TO SUCH AN OCCURRENCE. ANOTHER POSSIBLE REASON COULD BE INSTABLE FRACTURE WHICH LEAD TO MICRO MOVEMENT WHAT CAN CAUSE SUCH FRETTING AS WELL.

    Description of Event or Problem · 1

    INITIAL OPERATION WAS ON (B)(6) 2011. REMOVAL ATTEMPT WAS (B)(6) 2012. DURING THIS OPERATION FOLLOWING UNKNOWN DEVICES BROKE, ONE SCREWDRIVER, ONE CUTTING PLIERS AND ONE EXTRACTOR.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH 3.5MM TI LCP SUPERIOR ANTERIOR CLAVICLE PLATE AND SCREW CONSTRUCT ON AN UNKNOWN DATE. IT WAS REPORTED THE SURGEON COULD NOT REMOVE THE DEVICE FOR THE FIRST PLANNED REMOVAL OF HARDWARE AND THE SURGEON LEFT THE DEVICE IN PLACE. REPORTEDLY THE PATIENT DEVELOPED AN INFECTION. PATIENT WAS RETURNED TO THE OR ON AN UNSPECIFIED DATE FOR REMOVAL OF HARDWARE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE SECOND REVISION SURGERY. THIS REPORT IS FOR FIVE (5) UNKNOWN SCREWS. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT PERTAINS TO BROKEN INSTRUMENTS FROM INITIAL PLANNED REMOVAL ATTEMPT. THIS IS REPORT 3 OF 7 FOR (B)(4).

    Description of Event or Problem · 1

    THIS IS 3 OF 7 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289854 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention