BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 5492141 · Received March 10, 2016

    Report

    Report Number
    2520274-2016-11582
    Event Type
    Injury
    Date Received
    March 10, 2016
    Report Date
    February 25, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INITIALS ARE (B)(6). PATIENT WEIGHT IS UNKNOWN. THIS REPORT IS FOR FOUR (4) UNKNOWN LOCKING SCREWS. AN ADDITIONAL PRODUCT CODE POSSIBLE FOR THIS REPORT INCLUDES HWC. WITHOUT VALID PART AND LOT NUMBERS, THE UDI IS NOT AVAILABLE. THE ORIGINAL IMPLANT PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE IN (B)(6) 2015. PER FACILITY, THE COMPLAINANT PARTS WILL NOT BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). ALTHOUGH THE PART NUMBERS FOR EACH OF THE ASSOCIATED SCREWS ARE UNKNOWN, IT IS LIKELY THAT THE 510K NUMBER FOR THESE DEVICES IS K040762. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE 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 THAT A PATIENT SUSTAINED AN OPEN LEFT TIBIA FRACTURE ALONG WITH A COMPLICATED ACETABULAR FRACTURE ON AN UNKNOWN DATE. THE INJURY WAS ORIGINALLY TREATED WITH IRRIGATION AND DEBRIDEMENT PRIOR TO INITIAL FIXATION. IN (B)(6) 2015, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE DURING WHICH THE ACETABULAR FRACTURE WAS TREATED WITH THE IMPLANTATION OF A TIBIA NAIL. AT A POST-OPERATIVE FOLLOW-UP VISIT, A NON-UNION WAS DISCOVERED. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2016 TO EXPLANT ONE (1) TIBIA NAIL, FOUR (4) LOCKING SCREWS, AND ONE (1) END CAP. ALL OF THE ORIGINALLY IMPLANTED DEVICES WERE REMOVED INTACT. THE NON-UNION SIDE WAS TREATED WITH ILIAC BONE GRAFT AND THE INSERTION OF A NEW TIBIA NAIL CONSTRUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED SURGICAL DELAY. THE PATIENT¿S POST-OPERATIVE STATUS/OUTCOME WAS REPORTED AS ¿FINE.¿ THIS REPORT IS FOR FOUR (4) UNKNOWN LOCKING SCREWS. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147849 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention