BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.2MM GUIDE WIRE 400MM

    MDR report key: 16628398 · Received March 28, 2023

    Report

    Report Number
    8030965-2023-03745
    Event Type
    Injury
    Date Received
    March 28, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    07611819384194
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: PART:357.399S. LOT:9L88084. MANUFACTURING SITE: WERK SELZACH. SUPPLIER:FRÜH VERPACKUNGSTECHNIK AG. RELEASE TO WAREHOUSE DATE: 26 SEP 2022. EXPIRATION DATE: 01 SEP 2032. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART # 357.399. NON-STERILE LOT # 1254P04. MANUFACTURING SITE: WERK SELZACH. SUPPLIER:SYNTHES USA HQ, INC. RELEASE TO WAREHOUSE DATE:28 JUL 2022. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION(ORIF) SURGERY FOR FEMORAL NECK FRACTURE WITH THE FEMORAL NECK SYSTEM(FNS) IN QUESTION, ON (B)(6) 2023. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER ONE MONTH OF SURGERY, A REVISION SURGERY WAS PLANNED ON (B)(6) 2023, FOR AN UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.2MM GUIDE WIRE 400MM. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554440 3.2MM GUIDE WIRE 400MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 9L88084 07611819384194

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L.| BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH.| GUIDEWIRE Ø3.2 L400.| LOCKSCR Ø5 SELF-TAP L38 TAN.| PL 1-HO F/FEM NECK SYST TAN.