BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM VA-LCP MEDL DSTL HUMERUS PL 1H/LT/69MM-SHORT

    MDR report key: 8128697 · Received December 4, 2018

    Report

    Report Number
    2939274-2018-55240
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    January 1, 2018
    Report Date
    November 8, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982036728
    PMA / PMN Number
    K120070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IT WAS REPORTED NOT ALL THE DEVICES WERE REMOVED DURING THE EXPLANT PROCEDURE, BUT IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED AND WHICH REMAINED IN THE PATIENT. 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 · 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. EXACT DATE OF EVENT IS UNKNOWN, REPORTEDLY THE EVENT OCCURRED SOMETIME IN 2018. 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

    ADDITIONAL PRODUCT CODE HWC. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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. 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 A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018, DUE TO A NONUNION AND HARDWARE FAILURE. PATIENT INITIALLY HAD AN OPEN REDUCTION AND INTERNAL FIXATION SURGERY ON (B)(6) 2018, TO TREAT A LEFT DISTAL HUMERUS FRACTURE. THE IMPLANTED DEVICES WERE VARIABLE ANGLE DISTAL HUMERUS PLATE, VARIABLE ANGLE-LCP LAT DISTAL HUMERUS PLATE, EIGHT (8) VARIABLE ANGLE LOCKING SCREW SELF-TPING WITH T8 STARDRIVE, VARIABLE ANGLE LOCKING SCREW SELF-TPING WITH T8 STARDRIVE, VARIABLE ANGLE-LCP PROXIMAL OLECRANON, AND FOUR (4) ORTEX SCREW SELF- TAPPING. THE PROCEDURE WAS COMPLETED, AND ALL HARDWARE WAS REMOVED INTACT. THE FRACTURE WAS REDUCED, AND AN UNKNOWN VARIABLE ANGLE ELBOW PLATE WITH UNKNOWN SCREWS WERE USED FOR FIXATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS STABLE. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP MEDL DSTL HUMERUS PL 1H/LT/69MM-SHORT. THIS IS REPORT 10 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968950 2.7MM/3.5MM VA-LCP MEDL DSTL HUMERUS PL 1H/LT/69MM-SHORT PLATE,FIXATION,BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.117.501 10886982036728

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention