BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8445239 · Received March 22, 2019

    Report

    Report Number
    2939274-2019-57091
    Event Type
    Injury
    Date Received
    March 22, 2019
    Report Date
    February 27, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDS
    UDI-DI
    10886982095381
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 04.034.552S, LOT: H160612. MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: AUG 05, 2016, EXPIRY DATE: JUL 31, 2025. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT IMPLANT PROCEDURE. ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO INFECTION. DEVICES REMOVED WERE ONE (1) STERILE TITANIUM CANNULATED TIBIAL NAIL, ONE (1) 5MM DUAL CORE LOCKING SCREW, AND AN UNKNOWN QUANTITY OF 5MM LOCKING SCREWS. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS IS OKAY. THIS REPORT IS FOR ONE (1) TIBIAL NAIL. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT IMPLANT PROCEDURE. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF AN INFECTED TIBIAL NAIL. DEVICES REMOVED WERE ONE (1) STERILE TITANIUM CANNULATED TIBIAL NAIL, ONE (1) 5MM DUAL CORE LOCKING SCREW, AND AN UNKNOWN QUANTITY OF 5MM LOCKING SCREWS. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) TI TIBIAL NAIL. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237207 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE NAIL,FIXATION,BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.034.552S H160612 10886982095381

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention