BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/12 H/LT-STER

    MDR report key: 8644108 · Received May 27, 2019

    Report

    Report Number
    8030965-2019-64561
    Event Type
    Injury
    Date Received
    May 27, 2019
    Report Date
    April 29, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819521278
    PMA / PMN Number
    K121601
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 02.118.211S. LOT NUMBER: 7624470. PART MANUFACTURE DATE: 07-APR-2014. MANUFACTURING LOCATION: ELMIRA. PART EXPIRATION DATE: 01-MAR-2024 NONCONFORMANCE NOTED: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/12 H/LT-STER PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NONCONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPLAINED ISSUE (PLATE CRACKED) COULD NOT BE REPLICATED AND/OR CONFIRMED BASED ON THE AVAILABLE INFORMATION (INCL. PICTURES AND/OR X-RAY¿S). 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

    OCCUPATION: INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE 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. (B)(4). 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) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO SOME OF THE SCREWS WERE BROKEN AND THE PLATE WAS CRACKED. INITIALLY, THE PATIENT WAS IMPLANTED WITH VARIABLE ANGLE (VA) ANTEROLATERAL DISTAL PLATE TO FIX AN ANKLE FRACTURED APPROXIMATELY THREE YEARS AGO. AN INCIDENT WENT ON TO DELAYED UNION SO WAS BONE GRAFTED WITH THE PLATES IN SITU APPROXIMATELY A YEAR AGO. THIS HAS STILL NOT HEALED COMPLETELY AND SOME SCREWS HAVE BROKEN SO THE PLATE WAS REVISED TO LOCKING COMPRESSION PLATE (LCP) ANTEROLATERAL DISTAL TIBIA PLATE WITH A BONE GRAFT USING THE REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM FROM THE SAME FEMUR. THE REMOVED HARDWARE SHOWED FOUR (4) 2.7MM VA LOCKING SCREWS BROKE AT THE NECK, TWO (2) 2.7 MM VA LOCKING SCREWS WERE NOT BROKEN, A METAPHYSEAL SCREW WAS INTACT, TWO (2) 3.5MM VA LOCKING SCREWS WERE BROKEN, TWO (2) 3.5MM VA LOCKING SCREWS WERE INTACT, A CORTEX SCREW WAS INTACT AND A PLATE HAD A CRACK HALFWAY ACROSS IT INTO THE FIRST COMBI HOLE. THE PROCEDURE WAS COMPLETED WITH MINIMAL EXTRA INTERVENTION. THERE WAS NO SURGICAL DELAY AND NO ADVERSE EVENT TO THE PATIENT REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN 2.7MM VARIABLE ANGLE LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2). UNKNOWN 2.7MM METAPHYSEAL SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). 3.5MM VA LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2). UNKNOWN 3.5MM CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) . THIS REPORT IS FOR ONE (1) 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/12 H/LT-STER THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436840 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/12 H/LT-STER PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH 7624470 07611819521278

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention