BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA HP UNI ANTERIOR CHISEL

    MDR report key: 14207350 · Received April 26, 2022

    Report

    Report Number
    1818910-2022-07538
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    April 11, 2022
    Report Date
    April 26, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    FZO
    UDI-DI
    10603295084020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==(B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY : VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED ALLEGATION, THE DEVICE WAS FOUND BROKEN. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    CHISEL BROKE IN THE SIGMA UNI CUTTING BLOCK. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540623 SIGMA HP UNI ANTERIOR CHISEL KNEE INSTRUMENT : CUTTING INSTRUMENTS FZO DEPUY ORTHOPAEDICS INC US 2024-85-000 PG244706 10603295084020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown