BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 4141477 · Received October 4, 2014

    Report

    Report Number
    2520274-2014-13887
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 8, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN NAIL. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.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

    IT WAS REPORTED THE PATIENT HAD A FRACTURE AND THE DATE OF THE ORIGINAL SURGERY IS UNKNOWN. REPORTEDLY, THE PATIENT SUFFERED A NON-UNION ON AN UNKNOWN DATE. ON (B)(6) 2014, THE PATIENT UNDERWENT A REVISION SURGERY FOR REMOVAL OF A TIBIAL NAIL AND WHILE THE SURGEON WAS TAKING THE NAIL OUT TO PUT ANOTHER ONE IN, THE EXTRACTION SCREW WOULD NOT THREAD INTO THE NAIL. THE THREADS WERE WORN ON THE SCREW AND THE INSERTION HANDLE BENT. IT WAS ALSO REPORTED THAT THE SURGEON DID NOT USE THE INSERTION HANDLE TO REMOVE THE NAIL DURING REVISION SURGERY, IT WAS APPARENTLY BENT WHEN THE SURGEON WAS INSERTING THE NEW NAIL. THE NAIL THAT WAS INITIALLY REMOVED IN THE REVISION SURGERY IS NOT AVAILABLE; THERE ARE ALSO NO X-RAYS AVAILABLE. AS A RESULT THE SURGERY WAS DELAYED APPROXIMATELY TEN MINUTES. THERE WAS NO PATIENT HARM AND THE NAIL WAS EVENTUALLY REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR AN UNKNOWN NAIL. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621585 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention