BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL2 ANTERIOR BROACH HANDLE

    MDR report key: 10726941 · Received October 23, 2020

    Report

    Report Number
    1818910-2020-23216
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    January 1, 2020
    Report Date
    October 9, 2020
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    HTQ
    UDI-DI
    10603295230687
    PMA / PMN Number
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. H10 ADDITIONAL NARRATIVE: ADDED: D10. CORRECTED: H3. 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: EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT. DEPUY-SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. REMOVED: G5 (PROCODE/HTQ) AS THIS WAS ADDED IN ERROR.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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 · 1

    IT WAS REPORTED THAT THE HANDLE LOCKING MECHANISM IS WEAK. THE BROACH HANDLE DOES NOT STAY LOCKED. THE BROACHES FALL BECAUSE THE HANDLE IS WEAK. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194761 CORAIL2 ANTERIOR BROACH HANDLE HIP INSTRUMENTS : HANDLES HTQ DEPUY FRANCE SAS - 3003895575 952212500F SO2028370 10603295230687

    Patients

    Seq Age Sex Outcome Treatment
    1