BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WASHER 7.0MM

    MDR report key: 8331305 · Received February 12, 2019

    Report

    Report Number
    8030965-2019-60909
    Event Type
    Injury
    Date Received
    February 12, 2019
    Report Date
    January 23, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTN
    UDI-DI
    07611819270039
    PMA / PMN Number
    PREADM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. PART 419.980S, LOT 9180666: MANUFACTURING SITE: RARON. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: NOVEMBER 17, 2014. EXPIRY DATE: NOVEMBER 01, 2024. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF DEVICES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND STERILIZATION PARAMETER CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH 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. (B)(4). THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION LEADING TO DEVICE REMOVAL. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO AN INFECTION. INITIALLY, THE PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION (ORIF) FOR FOOT JOINT FRACTURE WITH ONE-THIRD TUBULAR PLATE, ONE (1) CANNULATED SCREW, THREE (3) 3.5MM CORTEX SCREWS L16 , ONE (1) 3.5MM CORTEX SCREW L24, ONE (1) CANCELLOUS SCREW, ONE (1) WASHER, AND ONE (1) GUIDE WIRE ON (B)(6) 2018. DURING AN INITIAL SURGERY, ONE-THIRD TUBULAR PLATE WAS USED IN THE FIBULA AND A CANNULATED SCREW WAS USED FOR THE TIBIA WERE BOTH IN QUESTIONS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY REPORTED. HOWEVER, FIVE (5) WEEKS AFTER THE SURGERY, THE AFFECTED SITE WAS INFECTED. THUS, A REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2019. THE PATIENT IS CURRENTLY STILL IN THE HOSPITAL UNDER TREATMENT THERAPY WITH ANTIBIOTICS AND UNDER OBSERVATION. THE SURGEON COMMENTED ABOUT THE CONTRIBUTING FACTOR IN WHICH A VACUUM ASSISTED CLOSURE THERAPY SUPPOSEDLY WAS STARTED FROM AN EARLY STAGE AFTER THE SURGERY, THUS, THE POSSIBILITY OF INFECTION WAS LOW. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) WASHER 7.0MM THIS REPORT IS 5 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126172 WASHER 7.0MM BOLT,NUT,WASHER HTN OBERDORF SYNTHES PRODUKTIONS GMBH 9180666 07611819270039

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention