BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/RT-STERILE

    MDR report key: 10928345 · Received December 1, 2020

    Report

    Report Number
    8030965-2020-09279
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    November 29, 2020
    Report Date
    November 30, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. H3, H6: PART: 04.003.260, LOT: L072832, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: 28.JUL.2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT THE NAIL IS BENT BY THE MOST PROXIMAL ¿IMPROVED LOCKING OPTIONS¿ HOLE ON THE DISTAL END. ADDITIONALLY, THERE IS A DISCOLOURED BULGE VISIBLE BY THIS MENTIONED HOLE, WHICH IS A RESULT OF THE BENDING. FURTHERMORE, THE CONNECTION SECTION HAS SOME SIGNS FROM USE, BUT OTHERWISE IS THE NAIL IN A GOOD CONDITION. DIMENSIONAL INSPECTION: FURTHERMORE, THE COMPLAINT RELEVANT HOLE CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, AS IT IS DEFORMED. DOCUMENT/SPECIFICATION REVIEW: DRAWINGS AND REVISIONS ARE IN ACCORDANCE TO DHR OF PRODUCTION LOT. ALL RELEVANT FEATURES ARE DEFINED ON THE USED DRAWING REVISIONS OF DHR OF PRODUCTION LOT. FURTHERMORE, ALL PARTS WENT THROUGH FINAL INSPECTION BEFORE THEY HAD LEFT THE PRODUCTION. SUMMARY: BASED ON THE DAMAGE AT THE RECEIVED PART, AND THE PROVIDED COMPLAINT DESCRIPTION, WE ARE ABLE CONFIRM THE COMPLAINT. THE MENTIONED DAMAGE FOUND BY VISUAL INSPECTION, CAN CLEARLY BE TRACED BACK TO USE. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS ITEM WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION WERE FOUND. MOREOVER, A REVIEW OF OUR COMPLAINTS DATA BASE SHOWS, THAT THERE ARE NO OTHER COMPLAINTS FOR THIS ISSUE FROM THIS ARTICLE AND LOT NUMBER. THE INVESTIGATION FOUND NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. THE BENT NAIL IS A CLEAR INDICATION FOR HIGH APPLIED FORCES DURING INSERTION. IT IS MOST LIKELY THAT THE NAIL WAS NOT PROPERLY ALIGNED TO THE FEMUR IN COMBINATION WITH HIGH APPLIED FORCES CAUSED THE DAMAGE OF THE NAIL WHICH FINALLY PREVENTED THE NAIL FROM BEING PROPERLY INSERTED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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. 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

    THIS REPORT IS FOR AN UNKNOWN NAIL/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE TIP OF THE LATERAL FEMORAL NAIL (LFN) WAS BENT DURING INSERTION. THIS WAS DISCOVERED ON THE POST OPERATIVE X-RAY. THE NAIL WAS REVISED. CONCOMITANT MEDICAL DEVICES: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) UNKNOWN NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392529 9MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/RT-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH L072832

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - SCREWS: TRAUMA| UNK - SCREWS: TRAUMA