BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - SCREWS: LOCKING

    MDR report key: 16534653 · Received March 13, 2023

    Report

    Report Number
    8030965-2023-03120
    Event Type
    Malfunction
    Date Received
    March 13, 2023
    Date of Event
    February 22, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    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. THIS REPORT IS FOR AN UNK - SCREWS: LOCKING: TRAUMA/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 JAPAN AS FOLLOWS: THIS PC IS RELATED TO (B)(4) WHICH REPORTS THAT PSEUDOARTHROSIS WAS CONFIRMED AFTER THE PRIMARY SURGERY. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE REVISION SURGERY BIPOLAR HIP HEMIARTHROPLASTY(BHA) WITH THE SCREWDRIVER (KSI¿S DEVICE). DURING THE REVISION SURGERY, THE SURGEON HAD A DIFFICULTY TO REMOVE THE LOCKING SCREW. ENGAGING WAS STRONG, AND THE LOCKING SCREW COULD NOT BE REMOVED. FINALLY, THE PLATE WAS CUT, AND THE LOCKING SCREW WAS REMOVED. REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH APPROXIMATELY 60 MINUTES DELAY. REMARKS: (B)(4) AND (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) (SYNTHES): SCREW, PLATE. (B)(4) (KSI): SCREWDRIVER. THIS REPORT IS FOR ONE (1) UNK - SCREWS: LOCKING: TRAUMA. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914442 UNK - SCREWS: LOCKING SCREW,FIXATION,BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PL 1-HO F/FEM NECK SYST TAN.| UNKNOWN SCREWDRIVER.