BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP DRILL SLEEVE 5 F/DRILL BITS Ø4.3

    MDR report key: 17100911 · Received June 9, 2023

    Report

    Report Number
    8030965-2023-07361
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    May 24, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    UDI-DI
    07611819246607
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: REPORTER IS A J&J SALES REPRESENTATIVE. H3/H6: DEVICE HISTORY LOT PART# 323.042, LOT # 2240165, MANUFACTURING SITE: WERK SELZACH LOGISTIK , RELEASE TO WAREHOUSE DATE: 12 FEB 2007, SUPPLIER: (B)(4), EXPIRATION DATE: N/A. 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 DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL TROCHANTERIC FRACTURE WITH LCP DRILL SLEEVE 5.0. WHILE CLEANING THE INSTRUMENTS AFTER SURGERY, IT WAS NOTICED THAT THE TIP THREADS OF THE LCP DRILL SLEEVE 5.0 WERE BROKEN. NO FRAGMENTS WERE CONFIRMED BY POST-OPERATIVE X-RAYS. THEREFORE, THERE IS NO POSSIBILITY OF LEAVING ANY REMAINS IN THE BODY. IT WAS NOT POSSIBLE TO DETERMINE AT WHAT POINT IN THE PREOPERATIVE AND POSTOPERATIVE CLEANING PROCESS THE FRAGMENT WAS BROKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) LCP DRILL SLEEVE 5 F/DRILL BITS Ø4.3. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453049 LCP DRILL SLEEVE 5 F/DRILL BITS Ø4.3 GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES GMBH 2240165 07611819246607

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown