BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7211559 · Received January 22, 2018

    Report

    Report Number
    2939274-2018-50367
    Event Type
    Injury
    Date Received
    January 22, 2018
    Report Date
    January 2, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982038418
    PMA / PMN Number
    K121601
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MED-WATCH, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE, AND A FOLLOW-UP MED-WATCH WILL BE FILED AS APPROPRIATE. 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

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 02.118.207S, LOT# H189012. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: OCT 04, 2016, EXPIRY DATE: AUG 31, 2026. 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 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. 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 ONE (1) BROKEN 2.7/3.5 MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) ANTEROLATERAL DISTAL TIBIA PLATE, ONE (1) BROKEN 3.5 MM CORTEX SCREW AND NONUNION CAUSED A PATIENT TO UNDERGO REVISION OF INITIALLY IMPLANTED DEVICES TO A TIBIAL NAIL ON (B)(6) 2018. THE INITIAL CONSTRUCT OF ONE (1) 2.7/3.5 MM VA-LCP ANTEROLATERAL DISTAL TIBIA PLATE WITH FIVE (5) LOCKING SCREWS AND THREE (3) PROXIMAL CORTEX SCREWS WERE IMPLANTED IN THE DISTAL TIBIA ALONG WITH ONE (1) 3.5 MM LCP RECON PLATE WITH THREE (3) 3.5 MM CORTEX SCREWS AND ONE (1) 3.5 MM LOCKING SCREW WERE IMPLANTED IN (B)(6) 2017. SUBSEQUENTLY, THE PATIENT DEVELOPED A NONUNION, AND THE 2.7/3.5 MM VA-LCP ANTEROLATERAL DISTAL TIBIA PLATE AND ONE (1) 3.5 MM CORTEX SCREW THAT WAS ATTACHED TO THE 3.5 MM LCP RECON PLATE BROKE. THE ENTIRE CONSTRUCT WAS REMOVED SUCCESSFULLY, INCLUDING THE SHAFT OF THE BROKEN 3.5 MM CORTEX SCREW THAT WAS BENEATH THE RECON PLATE. THE PATIENT WAS THEN IMPLANTED WITH ONE (1) UNKNOWN TIBIAL NAIL THROUGH A SUPRAPATELLAR APPROACH AND AN OPEN REDUCTION INTERNAL FIXATION OF THE FIBULA WAS PERFORMED TO TREAT THE NONUNION AND THE FRACTURE. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT ANY COMPLICATIONS, OR SURGICAL DELAY. MULTIPLE X-RAYS WERE TAKEN DURING THE REVISION PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THIS COMPLAINT INVOLVES TWO (2) DEVICES. CONCOMITANT DEVICES REPORTED: 2.7 MM VA LOCKING SCREW (PART# 02.211.044, LOT# UNKNOWN, QUANTITY# 2); 2.7 MM VA LOCKING SCREW (PART# 02.211.048, LOT# UNKNOWN, QUANTITY# 2); 2.7 MM VA LOCKING SCREW (PART# 02.211.024, LOT# UNKNOWN, QUANTITY# 1); 3.5 MM CORTEX SCREW (PART# 204.828, LOT# UNKNOWN, QUANTITY# 1); 3.5 MM CORTEX SCREW (PART# 204.824, LOT# UNKNOWN, QUANTITY# 1); 3.5 MM CORTEX SCREW (PART# 204.830, LOT# UNKNOWN, QUANTITY# 2); 3.5 MM CORTEX SCREW (PART# 204.826, LOT# UNKNOWN, QUANTITY# 1); 3.5 MM RECON PLATE (PART# 241.081). THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52823 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 H/LT-STER PLATE,FIXATION,BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.118.207S H189012 10886982038418

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention