BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT UNIVERSAL BROACH HANDLE

    MDR report key: 8974467 · Received September 9, 2019

    Report

    Report Number
    1818910-2019-103500
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    August 19, 2019
    Report Date
    August 19, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTQ
    UDI-DI
    10603295142843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. ADDITIONAL NARRATIVE: ADDED: EVALUATION CODES. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE WAS REVIEWED BY DEPUY ENGINEERING MELBOURNE IN A-3042410 WHICH STATES MY ASSESSMENT IS THAT THIS COMPLAINT IS DUE TO WEAR AND TEAR. ROOT CAUSE ATTRIBUTED TO THE DEVICE BEING WORN FROM NORMAL USE AND SERVICING. 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: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. INVESTIGATION SUMMARY ==> THE DEVICE WAS REVIEWED BY DEPUY ENGINEERING (B)(4) IN (B)(4) WHICH STATES MY ASSESSMENT IS THAT THIS COMPLAINT IS DUE TO WEAR AND TEAR. ROOT CAUSE ATTRIBUTED TO THE DEVICE BEING WORN FROM NORMAL USE AND SERVICING. 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 ==> NULL. DEVICE HISTORY BATCH ==> NULL. DEVICE HISTORY REVIEW ==> NULL.

    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

    PINNACLE CUP IMPACTOR BROKE DURING USE. C-STEM BROACH HANDLE WOULD NOT ACCEPT BROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771828 SUMMIT UNIVERSAL BROACH HANDLE HIP INSTRUMENTS : HANDLES HTQ DEPUY ORTHOPAEDICS INC US AK0905 10603295142843

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR