BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 SS

    MDR report key: 9349985 · Received November 20, 2019

    Report

    Report Number
    8030965-2019-70416
    Event Type
    Injury
    Date Received
    November 20, 2019
    Report Date
    October 22, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819425149
    PMA / PMN Number
    K103243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. H10 ADDITIONAL NARRATIVE: H3, H6: INVESTIGATION SUMMARY DEVICE HISTORY LOT : PART: 02.211.016S, LOT: 4L59743, MANUFACTURING SITE: SELZACH, SUPPLIER: FRUEH VERPACKUNGSTECHNIK AG, RELEASE TO WAREHOUSE DATE: MAY 10, 2019, EXPIRY DATE: MAY 01, 2029. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE EVALUATION HAS SHOWN THAT THIS SCREW WAS MANUFACTURED UNSTERILE UNDER PART 02.211.012 WITH LOT H844348 FIRST, THEREFORE AN DHR REVIEW ACTIVITY WAS ASSIGNED TO MONUMENT: MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: MAR 12, 2019, PART NUMBER: 202.211.016, 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM, LOT NUMBER: H844348, LOT QUANTITY: 197. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN-PROCESS / INSPECT DIMENSIONAL / FINAL INSPECTION, NS056862 REV H MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) LMD REV AD WAS REVIEWED AND DETERMINED TO BE CONFORMING. 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. COMPONENT PART(S) REVIEWED: PART NUMBER: 02.211.116.999, 2.8MM SCREW BLANK 16MM W/SD8 02.4 VAR ANGLE W/ES362SEC SS, LOT NUMBER: H790473, LOT QUANTITY: 919. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INSPECT WARM HEAD BLANK/INSPECT TURN HEAD AND POINT, NS072112 REV C MET ALL INSPECTION ACCEPTANCE CRITERIA. DEVICE HISTORY REVIEW. NOV 22, 2019: DHR REVIEWED. 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. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. 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 PATIENT UNDERWENT SURGERY FOR LEFT FIRST METATARSOPHALANGEAL JOINT FUSION ON (B)(6) 2018. A STANDARD TECHNIQUE WAS USED. THE FUSION WAS STABILIZED WITH A 42MM LEFT ZERO DEGREE 1.MTP FUSION PLATE REF 20.211.231S LOT H826318 (DEPUY SYNTHES). ON ABOUT 11/10/2019 THE PATIENT CONTACTED THE TREATMENT CENTRE WHERE I AM INFORMED THAT SUPERFICIAL INFECTION WAS DIAGNOSED AND FLUCLOXACILLIN STARTED. THE COMPLETE ABSENCE IN THE MEDICAL RECORDS OF THIS ENCOUNTER IS NOTED. I SAW THE PATIENT IN OUTPATIENT CLINIC ON (B)(6) 2019 FOR A PLANNED FOLLOW UP APPOINTMENT AND NOTED THE JOINT RED AND MORE SWOLLEN THAN IS USUALLY TO BE EXPECTED AND AN X-RAY TAKEN THAT DAY SHOWED THE FUSION PLATE TO HAVE BROKEN AND THE JOINT NOT FUSED WITH SOFT TISSUE SWELLING. ACTIVE MONITORING OF THE PATIENT, WITH POTENTIAL TO REMOVE METAL AND CARRY OUT REVISION SURGERY. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS 2 OF 5 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142165 VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 SS SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 4L59743 07611819425149

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention