BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12453540 · Received September 10, 2021

    Report

    Report Number
    2939274-2021-05298
    Event Type
    Injury
    Date Received
    September 10, 2021
    Report Date
    August 13, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10886982038135
    PMA / PMN Number
    K120854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D4 H4, H6: PRODUCT CODE: 02.118.111S LOT: 9709664 PER THE LOT MASTER RECORD MANUFACTURED DATE: NOVEMBER 19, 2015 A MANUFACTURING-RELATED POTENTIAL CAUSE WAS NOT SUSPECTED, THEREFORE, PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE, NO MANUFACTURING RECORD EVALUATION IS REQUIRED. PHOTO INVESTIGATION: THE DEVICE WAS NOT RETURNED. A PHOTO-INVESTIGATION WAS PERFORMED ON THE RECEIVED IMAGE. UPON INSPECTING THE IMAGE PROVIDED, NO ISSUES WERE FOUND WITH THE DEVICE. THE ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. CONCLUSION: THE COMPLAINT CONDITION CANNOT BE CONFIRMED DURING PHOTO INVESTIGATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO MANUFACTURING ISSUES WERE NOTED DURING INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. 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. H6 = HEALTH EFFECT - CLINICAL CODE.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. (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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF AN ANTERIORMEDIAL DISTAL TIBIA PLATE AND SCREWS DUE TO INFECTION AND NON-UNION. THE SURGEON REMOVED AN ANTERIORMEDIAL DISTAL TIBIA PLATE AND SCREWS ALONG WITH SOME CANNULATED SCREWS FROM THE DISTAL TIBIA. THE REASON FOR REMOVAL IS AN INFECTED NON UNION. THERE WERE NO ALLEGATIONS AGAINST THE DEVICES. THE SURGEON DECIDED NOT TO TAKE ALL THE HARDWARE OUT THAT DAY AND BRING THE PATIENT BACK AT A LATER DATE TO REMOVE THE REST OF IT. A DISTAL TIBIA PLATE AND SCREW REMAINED IN THE PATIENT. IT WAS ULTIMATELY DECIDED NOT TO REMOVE ANY MORE OF THE HARDWARE BECAUSE THE INFECTION WAS SUBSIDING. THE SURGEON PUT A CIRCULAR FIXATOR ON THE ANKLE FOR DEFINITIVE FIXATION. THIS PRODUCT WAS IMPLANTED IN (B)(6) 2020. THIS REPORT IS FOR (1) 2.7/3.5MM VA-LCP ANTEROMEDIAL DISTAL TIBIA PL/12 H/LT-STER. THIS IS REPORT 1 OF 17 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351327 2.7/3.5MM VA-LCP ANTEROMEDIAL DISTAL TIBIA PL/12 H/LT-STER SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.118.111S 9709664 10886982038135

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - SCREWS: 3.5 MM CORTEX| UNK - SCREWS: 3.5 MM CORTEX| UNK - SCREWS: 3.5 MM CORTEX| UNK - SCREWS: 4.0 MM CANNULATED| UNK - SCREWS: 4.0 MM CANNULATED| UNK - SCREWS: LOCKING: VARIABLE ANGLE| UNK - SCREWS: LOCKING: VARIABLE ANGLE| UNK - SCREWS: LOCKING: VARIABLE ANGLE| UNK - SCREWS: LOCKING: VARIABLE ANGLE| UNK - SCREWS: LOCKING: VARIABLE ANGLE| UNK - SCREWS: LOCKING: VARIABLE ANGLE| UNK - SCREWS: LOCKING: VARIABLE ANGLE| UNK - SCREWS: METAPHYSEAL| UNK - SCREWS: METAPHYSEAL| WASHER 7.0MM| WASHER 7.0MM| UNK - SCREWS: 3.5 MM CORTEX| UNK - SCREWS: 3.5 MM CORTEX| UNK - SCREWS: 3.5 MM CORTEX| UNK - SCREWS: 4.0 MM CANNULATED| UNK - SCREWS: 4.0 MM CANNULATED| UNK - SCREWS: LOCKING: VARIABLE ANGLE| UNK - SCREWS: LOCKING: VARIABLE ANGLE| UNK - SCREWS: LOCKING: VARIABLE ANGLE| UNK - SCREWS: LOCKING: VARIABLE ANGLE| UNK - SCREWS: LOCKING: VARIABLE ANGLE| UNK - SCREWS: LOCKING: VARIABLE ANGLE| UNK - SCREWS: LOCKING: VARIABLE ANGLE| UNK - SCREWS: METAPHYSEAL| UNK - SCREWS: METAPHYSEAL| WASHER 7.0MM| WASHER 7.0MM