BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CURVED BROAD LCP® PLATE 13 HOLES/247MM

    MDR report key: 8085718 · Received November 19, 2018

    Report

    Report Number
    2939274-2018-55021
    Event Type
    Injury
    Date Received
    November 19, 2018
    Report Date
    November 1, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10886982152183
    PMA / PMN Number
    K082807
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY LOT PART: 226.632, LOT: 2123079, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 14.MAR.2005. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH 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.

    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. H10: ADDITIONAL NARRATIVE: A1: PATIENT ID: (B)(4), B5, D4: LOT NUMBER, D11. B4/G4: INITIAL AWARENESS DATE SHOULD BE OCTOBER 31, 2018 NOT NOVEMBER 01, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON OCTOBER 31, 2018, THE PATIENT UNDERWENT A PLATE REMOVAL BECAUSE OF THE BROKEN 4.5MM CURVED BROAD LOCKING COMPRESSION PLATE. THERE WAS A SURGERY TO REPAIR THE NON-UNION OF THE FRACTURE. PATIENT REQUIRED ADDITIONAL INTERVENTION BECAUSE THE ORIGINAL FRACTURE HAD NOT YET HEALED WHEN THE BROKEN PLATE WAS REMOVED, DOCTOR IMPLANTED AN ANTEGRADE FEMORAL NAIL. SURGICAL DELAY IS UNKNOWN. PROCEDURE OUTCOME WAS SUCCESSFUL. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: LOCKING SCREWS (PART/LOT UNKNOWN, QUANTITY 11).

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: KTT, HRS. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION.THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A PLATE REMOVAL BECAUSE OF THE BROKEN 4.5MM CURVED BROAD LOCKING COMPRESSION PLATE. THIS SURGERY WAS TO REPAIR THE NON-UNION OF A FRACTURE. IT IS ALSO UNKNOWN IF THERE WERE A SURGICAL DELAY. PROCEDURE AND THE PATIENT'S OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924231 4.5MM CURVED BROAD LCP® PLATE 13 HOLES/247MM SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 212.211 2123079 10886982152183

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention