BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 315MM-STERILE

    MDR report key: 7526669 · Received May 18, 2018

    Report

    Report Number
    2939274-2018-52228
    Event Type
    Injury
    Date Received
    May 18, 2018
    Report Date
    April 26, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDS
    UDI-DI
    10886982095220
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PART 04.034.443S, LOT 6901146: RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET SPECIFICATION. INSPECTION SHEET FOR IN-PROCESS ACCEPTANCE MET INSPECTION ACCEPTANCE CRITERIA. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. 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

    (B)(6). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER. REVIEW/INVESTIGATION AS IT WAS REPORTEDLY DISCARDED BY THE FACILITY. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 THAT THE PATIENT UNDERWENT REMOVAL OF A TIBIAL NAIL AND FOUR (4) UNKNOWN LOCKING SCREWS ON (B)(6) 2018, DUE TO INFECTION. ALL HARDWARE WAS REMOVED INTACT. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS REPORTED AS SUCCESSFUL, THE FRACTURE HAD HEALED. THE HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2017. AFTER THE INITIAL SURGERY, THE PATIENT COMPLAINED ABOUT THE INTERLOCKING SCREW AND THEN ON A POST-OPERATIVE EXAM, INFECTION WAS IDENTIFIED AROUND THE NAIL AT THE SECOND DISTAL LOCKING SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368604 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 315MM-STERILE NAIL, FIXATION, BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.034.443S 6901146 10886982095220

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention