BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP ONE-THIRD TUBULAR PL COLLAR 5 H/57

    MDR report key: 11991917 · Received June 14, 2021

    Report

    Report Number
    2939274-2021-02908
    Event Type
    Injury
    Date Received
    June 14, 2021
    Report Date
    May 19, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982166852
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. PART NUMBER: 241.351. LOT NUMBER: H851485. PART MANUFACTURE DATE: N/A. MANUFACTURING LOCATION: N/A. PART EXPIRATION DATE: N/A. NONCONFORMANCE NOTED: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED AND THE LOT NUMBER PROVIDED DOES NOT MATCH THE PART NUMBER. A MANUFACTURING-RELATED POTENTIAL CAUSE WAS NOT SUSPECTED, THEREFORE, PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE NO MANUFACTURING RECORD EVALUATION IS REQUIRED. PHOTO INVESTIGATION: THE PART WAS NOT RETURNED FOR INVESTIGATION. A PHOTO INVESTIGATION WAS CARRIED OUT USING THE X-RAYS. THE PART WAS REMOVED FROM THE PATIENT BODY DUE TO A NON-UNION OF THE LEFT HUMERUS AND RIGHT TIBIA. THERE APPEARS TO BE NO ISSUES WITH THE PART FROM THE X-RAYS PROVIDED. A ROOT CAUSE OF THE ISSUE CANNOT BE DETERMINED FROM THE PROVIDED INFORMATION. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. CONCLUSION: THE COMPLAINT CONDITION CANNOT BE CONFIRMED BASED ON THE IMAGE PROVIDED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES, OR DISCREPANCIES WERE OBSERVED. NO MANUFACTURING ISSUES WERE NOTED DURING INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. 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

    PRODUCT COMPLAINT # (B)(4). WITHOUT A VALID LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. COMPLAINANT DEVICE 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. 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 AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION OF A MIDSHAFT NONUNION IN THE LEFT HUMERUS AND RIGHT TIBIA. IN PATIENT'S HUMERUS, DYNAMIC COMPRESSION PLATES WITH LIMITED BONE CONTACT (LC-DCP) AND NARROW DYNAMIC COMPRESSION PLATES WITH LIMITED BONE CONTACT (LC-DCP) WERE REMOVED, ALONG WITH TWELVE CORTEX SCREWS. PATIENT WAS REVISED TO A NEW LCDCP LARGE FRAGMENT PLATE AND BONE GRAFT HARVESTED FROM THE PATIENT¿S TIBIA. IN PATIENT'S TIBIA, LOCKING COMPRESSION PLATE (LCP) AND LOCKING COMPRESSION PLATE (LCP) TUBULAR PLATE WERE REMOVED, ALONG WITH TWENTY-ONE CORTEX SCREWS. A RIA WAS USED IN THE TIBIA TO RETRIEVE BONE GRAFT. SURGEON CORRECTED THE DEFORMITY, AND PATIENT¿S TIBIA WAS REVISED WITH A TIBIAL NAIL ADVANCED, AND PLACEMENT OF NEW SCREWS IN REMAINING TWO PLATES. FRAGMENT WERE GENERATED AND WAS REMOVED EASILY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FIVE MINUTES SURGICAL DELAY. THIS COMPLAINT INVOLVES FORTY-TWO (42) DEVICES. THIS REPORT IS FOR ONE LCP ONE-THIRD TUBULAR PL COLLAR 5 H/57 THIS REPORT IS FOR 13 OF THE 42 DEVICES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890961 LCP ONE-THIRD TUBULAR PL COLLAR 5 H/57 PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 241.351 H851485 10886982166852

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention