BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NECK FIX ANTI-ROTATION SCR L90 TAN

    MDR report key: 9376663 · Received November 26, 2019

    Report

    Report Number
    8030965-2019-70568
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    November 11, 2019
    Report Date
    November 8, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07612334089960
    PMA / PMN Number
    K172872
    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. 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, H6: STERILE-PART, PART: 04.168.490S, LOT: L893391, MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: MAY 03, 2018, EXPIRY DATE: MAY 01, 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE-PART, PART: 60123932, LOT: L872251, MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: APRIL 28, 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE RECEIVED DEVICES, 04.168.290S BOLT, 04.168.000S NECK FIX PLATE, 412.215S LOCKING SCREW, AND THE 04.168.490S ANTIROT SCREW SHOW SIGNS OF USE SUCH AS MECHANICAL DAMAGES ON ENTIRE PART'S SURFACES. THE ANODIZED LAYER IS WORN AWAY AT THE DAMAGES WHICH INDICATES THAT THEY WERE CAUSED POST-MANUFACTURING. ALL FEATURES RELATED TO THE REPORTED COMPLAINT CONDITION WERE REVIEWED AND NO OTHER ISSUES WERE IDENTIFIED. SUMMARY: OUR INVESTIGATION HAS SHOWN THAT THE RECEIVED DEVICES HAVE SIGNS OF USE ON THEIR SURFACES. THESE DAMAGES ARE CLEARLY CAUSED POST MANUFACTURING, CONSIDERING THE EVIDENCE THAT ANODIZED LAYER IS PARTIALLY DISAPPEARED. REVIEWING THE PROVIDED X-RAYS, THERE IS NO INDICATION THAT THE PRODUCTS HAVE LED TO THE DISORDER. HOWEVER,THIS INVESTIGATION WILL BE RATED AS UNCONFIRMED, BECAUSE NO PRODUCT RELATED ISSUE WAS IDENTIFIED. FINALLY, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. 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. IP-(B)(4), PART NUMBER: 04.168.490, MANUFACTURED DATE: 4/28/2018. 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

    ADDITIONAL EVENT INFORMATION IP-(B)(4): PART NUMBER: 04.168.000 MANUFACTURED DATE: 2/25/2019. IP-(B)(4): PART NUMBER: 04.168.290 MANUFACTURED DATE: 6/5/2018. IP-(B)(4): PART NUMBER: 04.168.490 MANUFACTURED DATE: 4/28/2018. IP-(B)(4): PART NUMBER: 412.215.

    Additional Manufacturer Narrative · 1

    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. (B)(4). 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 ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FEMORAL NECK FRACTURE WITH THE FNS IN QUESTION. ON (B)(6) 2019, THE PATIENT REPORTED PAIN AND HE HAD X-RAYS. X-RAYS SHOWED THAT THE BONE HEAD SHORTENED, AND IT WAS VALGUS, AND THE BOLT WAS TELESCOPED FULLY. ON (B)(6) 2019, THE PATIENT UNDERWENT THE REVISION SURGERY. IN THE REVISION SURGERY, THE SURGEON REMOVED THE FNS AND IMPLANTED AN ARTIFICIAL FEMORAL BONE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY IN ABOUT 2 HOURS. THE SURGEON COMMENTED THAT THE FNS WAS NOT OFF-LABEL USE BECAUSE THE RETROVERSION DIDN'T OCCUR. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS IS 3 OF 4 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171291 NECK FIX ANTI-ROTATION SCR L90 TAN APPLIANCE, FIXATION, NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L872251 07612334089960

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention