BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/75MM

    MDR report key: 7406656 · Received April 9, 2018

    Report

    Report Number
    2939274-2018-51541
    Event Type
    Injury
    Date Received
    April 9, 2018
    Report Date
    March 14, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10886982062222
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. REPORT DATE: DATE REPORTED IN INITIAL MEDWATCH WAS 3/15/2018. CORRECT DATE SHOULD HAVE BEEN 3/14/2018. PHYSICAL MANUFACTURE LOCATION. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PATIENT (B)(6); PATIENT AGE, DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING IT IS UNKNOWN WHEN NON-UNION BEGAN. ADDITIONAL PRODUCT CODE JDP, HWC. IMPLANT DATE IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UPDATED PROCODE; ADDITIONAL PRODUCT CODES JDP, HRS. 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, A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FEMUR USING SYNTHES VA CONDYLAR PLATE AND SCREWS. THE OUTCOME OF THE SURGERY WAS A NONUNION. ON (B)(6) 2018 THE SURGEON PERFORMED A REVISION ORIF OF THE DISTAL FEMUR TO ADDRESS THE NONUNION. THE PLATES AND SCREWS WERE INTACT AND SUCCESSFULLY REMOVED. A BONE GRAFT WAS INSERTED AND A NEW SYNTHES VA CONDYLAR PLATE AND SCREWS WERE INSERTED IN THE PATIENT. THE REVISION WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THIS IS REPORT 2 OF 8 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252533 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/75MM SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.231.275 10886982062222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention