BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPERT TN ø10 SOLID L300 TAN LIGHT GREEN

    MDR report key: 16682696 · Received April 5, 2023

    Report

    Report Number
    8030965-2023-04159
    Event Type
    Injury
    Date Received
    April 5, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819196445
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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.

    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. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. 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

    DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN GERMANY AS FOLLOWS: THE SITE MZU (MAINZ, GERMANY) REPORTED AN ADVERSE EVENT IN OUR DATABASE WHICH IS CONSIDERED (POSSIBLY) RELATED TO THE DEVICE: CLINICAL TRIAL SUBJECT MZU-004 IT WAS REPORTED THE PATIENT SUSTAINED A HIGH TRAUMA INJURY OF THE LEFT TIBIA ON (B)(6) 2021. IT WAS AN OPEN 42C3 CLASSIFICATION FRACTURE. ADDITIONAL INJURIES OF LEFT FIBULA (EXCLUDING LATERAL MALLEOLAR FRACTURES) AND LEFT MALLEOLAR REGION WERE SUSTAINED. INITIAL SURGICAL TREATMENT OCCURRED ON (B)(6) 2021 WITH AN EXTERNAL FIXATOR AND SANCHEZ SCREWS. SURGICAL PLAN WAS 2 STAGED. ON (B)(6) 2021 SECOND PROCEDURE WAS COMPLETED WITH A NAIL CONSTRUCT. COMPRESSION PLATE USED TO TREAT THE FIBULA FRACTURE. ON (B)(6) 2021 NON-UNION WAS NOTED AND PATIENT WAS NOT ABLE TO BEAR WEIGHT. MALUNION(>5 DEGREES VARUS-VALGUS, >10 DEGREES MALROTATION, AND >1 CM SHORTENING) WAS NOTED. ON (B)(6) 2022 BONE UNION HAD NOT YET BEEN ACHIEVED AND PATIENT WAS STILL UNABLE TO BEAR WEIGHT. MALUNION WAS STILL PRESENT. ON (B)(6) 2022, PATIENT WAS EXPERIENCING PAIN AND AGAIN BONE UNION HAD NOT YET BEEN ACHIEVED. MORE EXTENSIVE MALUNION AND MALALIGNMENT WAS NOTED. PATIENT STILL UNABLE TO BEAR WEIGHT. IT WAS ADDITIONALLY REPORTED DEVICE BREAKAGE HAD OCCURRED. PATIENT WAS REVISED TO A PLATE ON (B)(6) 2022. ON (B)(6) 2022, SURGICAL REVISION AND SURGICAL INTERVENTION WAS REQUIRED TO FILL BONE DEFECT BY CANCELLOUS BONE TO HELP WITH THE NON-UNION. IT WAS NOTED PATIENT WAS LISTED AS RECOVERED ON (B)(6) 2023. (B)(4) IS RELATED TO (B)(4). (B)(4) WAS CREATED TO CAPTURE NON-UNION. THIS REPORT IS FOR ONE (1) EXPERT TN ø10 SOLID L300 TAN LIGHT GREEN. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008353 EXPERT TN ø10 SOLID L300 TAN LIGHT GREEN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 07611819196445

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention UNK - SCREWS: NAIL DISTAL LOCKING| UNK - SCREWS: NAIL DISTAL LOCKING| UNK - SCREWS: NAIL DISTAL LOCKING| UNK - SCREWS: NAIL PROXIMAL LOCKING| UNK - SCREWS: NAIL PROXIMAL LOCKING