BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/LEFT

    MDR report key: 7957210 · Received October 11, 2018

    Report

    Report Number
    2939274-2018-54303
    Event Type
    Injury
    Date Received
    October 11, 2018
    Report Date
    September 26, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982038869
    PMA / PMN Number
    K120854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DESCRIPTION WITH EXPLANTATION DATE. CORRECTED DATA: ADDITIONAL PRODUCT CODE: HWC. 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 · 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 , PART MFG DATE: 09-JUN-2017 , PART EXP. DATE: N/A, MANUFACTURING LOCATION: DEPUY SYNTHES ¿ ELMIRA, LOT NUMBER: H380262, PART NUMBER: 02.118.403. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO NON-CONFORMANCES. THE DHR SHOWS LOT# H380262 OF 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/LEFT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THIS 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. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING 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 · 0

    IT WAS REPORTED THAT ON AN (B)(6) 2018 THE PATIENT UNDERWENT HARDWARE REMOVAL OF ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) LATERAL DISTAL FIBULA PLATE, ONE (1) LCP LOW BEND MEDIAL DISTAL TIBIA PLATE, FIVE (5) 2.7 VA LOCKING SCREWS, FOUR (4) 3.5 CORTEX SCREWS, ONE (1) 4.0 CANNULATED SCREW, FOUR (4) 2.7 CORTEX SCREWS, AND FIVE (5) VARIABLE ANGLE (VA) LOCKING SCREWS DUE TO PAIN. THE PATIENT WILL EVENTUALLY NEED AN ANKLE FUSION. THE DEVICES WERE ORIGINALLY IMPLANTED ON DECEMBER 11, 2017. ALL IMPLANTS WERE REMOVED SUCCESSFULLY WITH NO ISSUES. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: K120854. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY LOT: PART MFG DATE: 09-JUN-2017 ; PART EXP. DATE: N/A; MANUFACTURING LOCATION: DEPUY SYNTHES ¿ (B)(4); LOT NUMBER: H380262; PART NUMBER: 02.118.403. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO NON-CONFORMANCES. THE DHR SHOWS LOT# H380262 OF 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/LEFT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCE OR REWORK NOTED. THIS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT HARDWARE REMOVAL OF ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) LATERAL DISTAL FIBULA PLATE, ONE (1) LCP LOW BEND MEDIAL DISTAL TIBIA PLATE, FIVE (5) 2.7 VA LOCKING SCREWS, FOUR (4) 3.5 CORTEX SCREWS, ONE (1) 4.0 CANNULATED SCREW, FOUR (4) 2.7 CORTEX SCREWS, AND FIVE (5) VARIABLE ANGLE (VA) LOCKING SCREWS DUE TO PAIN. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2017. ALL IMPLANTS WERE REMOVED SUCCESSFULLY WITH NO ISSUES. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN DEVICES TOTALING (21). THIS COMPLAINT IS FOR (1) 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE. THIS REPORT IS 1 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798549 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/LEFT PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.118.404 H380262 10886982038869

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention