BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: NAIL PROXIMAL LOCKING

    MDR report key: 16682700 · Received April 5, 2023

    Report

    Report Number
    8030965-2023-04165
    Event Type
    Injury
    Date Received
    April 5, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    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 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. ADDITIONAL NARRATIVE: 510K: THIS REPORT IS FOR AN UNK - SCREWS: NAIL PROXIMAL LOCKING/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES 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-004IT WAS REPORTED THE PATIENT SUSTAINED A HIGH TRAUMA INJURY OF THE LEFT TIBIA ON 11 JUNE 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 11 JUNE 2021 WITH AN EXTERNAL FIXATOR AND SANCHEZ SCREWS. SURGICAL PLAN WAS 2 STAGED. ON 16 JUNE 2021 SECOND PROCEDURE WAS COMPLETED WITH A NAIL CONSTRUCT. COMPRESSION PLATE USED TO TREAT THE FIBULA FRACTURE.ON 07 OCTOBER 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 12 APRIL 2022 BONE UNION HAD NOT YET BEEN ACHIEVED AND PATIENT WAS STILL UNABLE TO BEAR WEIGHT. MALUNION WAS STILL PRESENT. ON 02 AUGUST 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 10 AUGUST 2022. ON 23AUGUST 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 10 JANUARY 2023.PC-001322888 IS RELATED TO PC-001317561.PC-001322888 WAS CREATED TO CAPTURE NON-UNION.THIS REPORT IS FOR ONE (1) UNK - SCREWS: NAIL PROXIMAL LOCKING.THIS IS REPORT 2 OF 6 FOR COMPLAINT PC-001322888.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009222 UNK - SCREWS: NAIL PROXIMAL LOCKING SCREW,FIXATION,BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention EXPERT TN ø10 SOLID L300 TAN LIGHT GREEN| UNK - SCREWS: NAIL DISTAL LOCKING| UNK - SCREWS: NAIL DISTAL LOCKING| UNK - SCREWS: NAIL DISTAL LOCKING| UNK - SCREWS: NAIL PROXIMAL LOCKING