BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE

    MDR report key: 7707376 · Received July 20, 2018

    Report

    Report Number
    2939274-2018-53004
    Event Type
    Injury
    Date Received
    July 20, 2018
    Report Date
    June 29, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDS
    UDI-DI
    1088698209538
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE 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. DHR REVIEW WAS COMPLETED. MANUFACTURING LOCATION: MONUMENT. MANUFACTURING DATE: 24-JAN-2012. EXPIRATION DATE: DEC-2020. P/N 04.034.552S, LOT # 6860625 (STERILE); 11MM TI CANN TIBIAL NAIL; EX W/PROX BEND 360MM-STERILE. LOT QUANTITY: 6. INSPECTION SHEET FOR IN-PROCESS ACCEPTANCE MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECT DIMENSIONAL SHEET MET ALL INSPECTION ACCEPTANCE CRITERIA. FINAL INSPECTION SHEET MET ALL INSPECTION ACCEPTANCE CRITERIA. NO NRS WERE GENERATED DURING THE PRODUCTION OF THIS LOT. 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. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    PATIENT¿S HEIGHT REPORTED AS 5 FEET 8 INCHES. THIS PATIENT INFORMATION IS UNKNOWN. ORIGINAL IMPLANT DATE IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 AND IS CURRENTLY PENDING COMPLETION. 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 HARDWARE REMOVAL ON (B)(6) 2018 DUE TO OSTEOMYELITIS. AFTER THE SUCCESSFUL HEALING OF THE PATIENT'S FRACTURE, ONE (1) TITANIUM CANNULATED TIBIAL NAILS-EX WITH PROXIMAL BEND, SIX (6) UNKNOWN DISTAL 5.0MM LOCKING SCREWS, ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE AND FOUR (4) UNKNOWN 3.5MM LOCKING SCREWS HAD TO BE REMOVED. ORIGINAL IMPLANT DATE WAS UNKNOWN. THE OSTEOMYELITIS WAS REPORTED AS CELLULITIS, AS THIS IS A BACTERIAL SKIN INFECTION, THE REPORTER WAS UNAWARE OF THE SOURCE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT CONSEQUENCE WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547466 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE NAIL, FIXATION, BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6860625 1088698209538

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention