BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4/2.7MM VA-LCP FIRST MTP FUSION PL/SM/10 DEG/RIGHT

    MDR report key: 8718017 · Received June 20, 2019

    Report

    Report Number
    2939274-2019-58784
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Report Date
    May 24, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982054180
    PMA / PMN Number
    K100776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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. H3, H6 INVESTIGATION SUMMARY THE 2.4/2.7MM VA-LCP FIRST MTP FUSION PL/SM/10 DEG/RIGHT (P/N 02.211.234 LOT 9940289) WAS RECEIVED SHOWING NO DEFECTS OR DEFORMITIES. THE PLATE WAS NOT OBSERVED TO HAVE ANY BENDING DEFORMITY. THE PLATE IS MANUFACTURED WITH A PRECONTOUR FOR APPLICATION. NO EXPANSION OR THINNING OF THE PLATE MATERIAL WAS OBSERVED TO INDICATE ANY BENDING. THE COMPLAINT IS NOT CONFIRMED DIMENSIONAL INSPECTION: DRAWING: 2.4MM/2.7MM VA-LCP FIRST MTP FUSION PLATE , FEATURE: CROSS SECTION K-K, PLATE THICKNESS, SPECIFICATION: 1.8 MM +/- 0.1 MM, MEASURED DIMENSION: 1.75 MM, RESULT: CONFORMING, MEASUREMENT DEVICE: CALIPER CA802. THE FOLLOWING DRAWING, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WAS REVIEWED. - 2.4MM/2.7MM VA-LCP FIRST MTP FUSION PLATE DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE COMPLAINT CONDITION IS NOT CONFIRMED FOR THE 2.4/2.7MM VA-LCP FIRST MTP FUSION PL/SM/10 DEG/RIGHT (P/N 02.211.234 LOT 9940289) AS THE PLATE WAS NOT OBSERVED TO HAVE ANY BENDING DEFORMITY. IT IS POSSIBLE THAT DURING ROUTINE INSPECTION, THE REPORTER THOUGHT THAT THE PLATE WAS NOT MANUFACTURED WITH A PRECONTOUR. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. H4 DEVICE HISTORY REVIEW PART NUMBER: 02.211.234, LOT NUMBER: 9940289, PART MANUFACTURE DATE: 09-NOV-2015, MANUFACTURING LOCATION: ELMIRA, PART EXPIRATION DATE: N/A, 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 2.4/2.7MM VA-LCP FIRST MTP FUSION PL/SM/10 DEG/RIGHT 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRO-CODE, HWC. THE DEVICE WAS RECEIVED. SYNTHES SALES REP. THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. 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 UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION, THE VARIABLE ANGLE LOCKING COMPRESSION PLATE FIRST METATARSOPHALANGEAL (MTP) WAS FOUND BENT. THERE WAS NO PATIENT INVOLVEMENT.  THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511593 2.4/2.7MM VA-LCP FIRST MTP FUSION PL/SM/10 DEG/RIGHT PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.211.234 9940289 10886982054180

    Patients

    Seq Age Sex Outcome Treatment
    1