BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL NAIL-ADVANCED / 10 360 / STERILE

    MDR report key: 14642330 · Received June 9, 2022

    Report

    Report Number
    9612488-2022-00018
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    January 1, 2022
    Manufacturer
    SYNTHES PRODUKTIONS GMBH
    Product Code
    JDS
    UDI-DI
    10886982297792
    PMA / PMN Number
    K201336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. ADDITIONAL PRODUCT CODE: HWC. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. 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.

    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, H4, H6 INVESTIGATION SUMMARY: THE PHOTO WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE FROM ATTACHMENT. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE PROXIMAL INLAY CAN BE SEEN LOOSENED ON THE SURFACE OF THE TIBIAL NAIL-ADVANCED / 10 360 / STERILE. A FUNCTIONAL TEST WAS NOT CONDUCTED DUE TO THE IMPACTED PRODUCT NOT BEING RETURNED FOR EXAMINATION. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR TIBIAL NAIL-ADVANCED / 10 360 / STERILE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY: PART # 04.043.240S. LOT # 519P721. MANUFACTURING SITE: JABIL BETTLACH. RELEASE TO WAREHOUSE DATE: 08.DECEMBER.2021. EXPIRY DATE: 31.OCTOBER.2031. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT AND NO NON-CONFORMANCE WAS IDENTIFIED. 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 UNKNOWN DATE, THE SURGEON WAS INSERTING THE NAIL OVER THE BALL TIP WIRE, THE PROXIMAL POLY INLAY SLEEVE GOT HUNG UP ON THE TOP OF THE WIRE AND WOULD NOT ALLOW THE NAIL TO ADVANCE. AFTER MULTIPLE TRIES THE INLAY SLID UP THE NAIL AND OUT OF PLACE. THE NAIL WAS REMOVED AND REPLACED WITH ANOTHER NAIL OF SAME DIAMETER AND LENGTH, 10X360 TIBIAL NAIL ANS. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: NAIL PROXIMAL LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN), UNK - GUIDES/SLEEVES/AIMING: SLEEVE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1)TIBIAL NAIL-ADVANCED / 10 360 / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027147 TIBIAL NAIL-ADVANCED / 10 360 / STERILE NAIL, FIXATION, BONE JDS SYNTHES PRODUKTIONS GMBH 04.043.240S 519P721 10886982297792

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male UNK - GUIDES/SLEEVES/AIMING: SLEEVE| UNK - SCREWS: NAIL PROXIMAL LOCKING