BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/85MM

    MDR report key: 9705697 · Received February 13, 2020

    Report

    Report Number
    2939274-2020-00799
    Event Type
    Injury
    Date Received
    February 13, 2020
    Report Date
    January 22, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982166883
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    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 LOT PART NUMBER: 241.37, LOT NUMBER: 7820676, PART MANUFACTURE DATE: 10 OCT 2014, MANUFACTURING LOCATION: ELMIRA, PART EXPIRATION DATE: N/A, NONCONFORMANCE NOTED: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF ONE-THIRD TUBLUAR PLATE WITH COLLAR 7 HOLES/85MM WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THE LOT QUANTITY OF (B)(4) PIECES MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY BATCH PART NUMBER: 316L**PI9.00X1.00, LOT NUMBER: 7617332, PART MANUFACTURE DATE: 25 FEB 2014, MANUFACTURING LOCATION: ELMIRA, PART EXPIRATION DATE: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF ONE-THIRD TUBLUAR PLATE WITH COLLAR 7 HOLES/85MM WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OP. 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

    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. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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. (B)(4). 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 ON AN UNKNOWN DATE THERE WAS A HARDWARE REMOVAL OF THE ONE THIRD TUBULAR PLATE WITH 7 HOLES AND UNKNOWN SCREWS DUE TO INFECTION. THE TUBULAR PLATE AND UNKNOWN SCREWS WERE IMPLANTED ON AN UNKNOWN DATE. AFTER THE PROCEDURE, THERE WAS A PRESENCE OF INFECTION. PROCEDURE WAS SUCCESSFULLY COMPLETED AND ALL HARDWARE WERE REMOVED. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS 1 OF 8 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171272 ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/85MM PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 241.37 7820676 10886982166883

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention