BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-STEM NECK RESECTION CALIPER

    MDR report key: 14778500 · Received June 22, 2022

    Report

    Report Number
    1818910-2022-11515
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Report Date
    June 22, 2022
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KTZ
    UDI-DI
    10603295251422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. 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

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED FOR EXAMINATION, THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, A NECK RESECTION CALIPER IS MISSING THE SCREW FROM THE TOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331538 C-STEM NECK RESECTION CALIPER HIP INSTRUMENTS : SIZING/MEASURING INSTRUMENTS KTZ DEPUY INTERNATIONAL LTD - 8010379 9751-90-000 10603295251422

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown