BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI END CAP W/T40 STRDRV 15MM EXT-STER F/TI TIBIAL NAILS-EX

    MDR report key: 7976122 · Received October 17, 2018

    Report

    Report Number
    8030965-2018-57402
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Report Date
    October 4, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDS
    UDI-DI
    07611819172678
    PMA / PMN Number
    K040762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. STERILE PART 04.004.003S, LOT L990981: MANUFACTURING SITE: SELZACH. SUPPLIER: FRÜH VERPACKUNGSTECHNIK AG. RELEASE TO WAREHOUSE DATE: JULY 27, 2018. EXPIRY DATE: JULY 01, 2028. NON-STERILE PART 04.004.003, LOT L940629: MANUFACTURING SITE: MEZZOVICO. RELEASE TO WAREHOUSE DATE: JUNE 20, 2018. THE STERILIZATION HISTORY RECORD SHOWS THAT THIS LOT OF DEVICES WAS PROCESSED THROUGH THE NORMAL STERILIZATION AND INSPECTION OPERATIONS WITH NO NONCONFORMITIES NOTED. THE IRRADIATION CERTIFICATE DOES CERTIFY THAT ALL READINGS ARE WITHIN THE SPECIFIED RANGE. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF DEVICE WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE STERILIZATION HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE STERILIZATION PROCEDURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 NOTED THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTEDLY STABLE AFTER SURGERY. NO ADDITIONAL INTERVENTION WAS REQUIRED.

    Additional Manufacturer Narrative · 1

    DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THAT A PROCEDURE FOR EXPERT TIBIA NAIL INSERTION WAS PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SURGICAL TEAM WAS HAVING TROUBLE TO GET THE 10MM TITANIUM END CAP ON THE EXPERT TIBIAL NAIL IN PLACE. THE THREADS DID NOT SEEM TO REALLY FIT, AND IT WAS HARD TO GET IN PLACE ON THE TIBIA NAIL. THE INSERTION OF THE END CAP TOOK LONGER THAN THE INSERTION OF THE NAIL. EXPERT TIBIA END CAPS WERE CONFIRMED TO BE CORRECT AS PER THE ARTICLE NUMBERS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. CONCOMITANT: EXPERT TIBIAL NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) TI END CAP W/T40 STRDRV 15MM EXT-STER F/TI TIBIAL NAILS-EX . THIS IS REPORT 5 OF 8 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814841 TI END CAP W/T40 STRDRV 15MM EXT-STER F/TI TIBIAL NAILS-EX NAIL, FIXATION, BONE JDS OBERDORF SYNTHES PRODUKTIONS GMBH L990981 07611819172678

    Patients

    Seq Age Sex Outcome Treatment
    1