BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 H/LT-STER

    MDR report key: 11992604 · Received June 14, 2021

    Report

    Report Number
    8030965-2021-04904
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    April 30, 2021
    Report Date
    June 7, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    UDI-DI
    10886982038418
    PMA / PMN Number
    K121601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. DEVICE HISTORY LOT: MANUFACTURING LOCATION: ELMIRA / PACKAGED, STERILIZED AND RELEASED BY: MONUMENT. RELEASE TO WAREHOUSE DATE: 19-NOV-2019. EXPIRATION DATE: 01-NOV-2029. PART NUMBER: 02.118.207S, 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 H/LT-STERILE. LOT NUMBER: 26P9224 (STERILE). NOTE: PLATE WAS MANUFACTURED BY ELMIRA; LOT NUMBER 21P0051. PARTS WERE PACKAGED, STERILIZED AND RELEASED BY MONUMENT. PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) LMD REV AC WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. SCN 16858 SUPPLIED BY STERIGENICS WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY REVIEW: THIS LOT MET ALL VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT 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 · 1

    ADDITIONAL PROCODE: HWC. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. 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 ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE VA-LCP DISTAL TIBIAL PLATE COULD NOT FIT THE VA SCREW IN ONE OF THE HOLES. THE SURGEON ATTEMPTED TO USE ANOTHER SCREW BUT THAT DID NOT FIT INTO THE PLATE HOLE EITHER. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 H/LT-STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891368 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 H/LT-STER PLATE,FIXATION,BONE HRS SYNTHES GMBH 02.118.207S 25P6747 10886982038418

    Patients

    Seq Age Sex Outcome Treatment
    1