BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/5H SHAFT/LT-STER

    MDR report key: 8501451 · Received April 10, 2019

    Report

    Report Number
    8030965-2019-62679
    Event Type
    Injury
    Date Received
    April 10, 2019
    Report Date
    March 21, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819354425
    PMA / PMN Number
    K083694
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. PICTURE REVIEW WAS CONDUCTED: NARRATIVE (PLATE BREAKAGE) COULD BE VERIFIED FROM PROVIDED PICTURES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 04.111.651S, LOT: L051171, MANUFACTURING SITE: MEZZOVICCO, RELEASE TO WAREHOUSE DATE: 20 JULY 2016, EXPIRY DATE: 01 JULY 2026, LOT L051171 WAS MANUFACTURED FROM BLANK 60062499 LOT L040023, MANUFACTURING SITE: MEZZOVICCO, RELEASE TO WAREHOUSE: 17 JUNE 2016 . THE RAW MATERIAL CERTIFICATE 19085 WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO ISO-5832-2 SPECIFICATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION DUE TO BROKEN VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) TWO-COLUMN VOLAR DISTAL RADIUS PLATE FEW DAYS AFTER THE SURGERY FOR AN UNKNOWN REASON. ORIGINALLY, THE PATIENT HAD AN IMPLANTATION OF THE VA-LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE AND UNKNOWN SCREWS, ON AN UNKNOWN DATE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT IDENTIFIER REPORTED AS: (B)(6). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) TWO-COLUMN VOLAR DISTAL RADIUS PLATE WAS BROKEN FEW DAYS AFTER SURGERY DUE TO UNKNOWN REASON. IT WAS UNKNOWN IF THE REVISION SURGERY OR HARDWARE REMOVAL IS REQUIRED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 2.4MM TI VA-LCP 2-COLUMN VOLAR DISTAL RADIUS PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291587 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/5H SHAFT/LT-STER PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH L051171 07611819354425

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention