BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S/C TRIAL HANDLE ANGLED

    MDR report key: 15692987 · Received October 28, 2022

    Report

    Report Number
    1818910-2022-21526
    Event Type
    Malfunction
    Date Received
    October 28, 2022
    Date of Event
    January 1, 2022
    Report Date
    October 28, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWA
    UDI-DI
    10603295084488
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (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: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE PART DID NOT EXHIBIT FOREIGN SUBSTANCES WHICH COULD AFFECT FUNCTIONALITY AND/OR APPEARANCE. 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: QUANTITY MANUFACTURED: (B)(4) PCS. DATE OF MANUFACTURE: 5/9/2022. ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: 1 QHF WAS FOUND FOR UNIFORM FINISH ON TOP OF POST. EXPIRY DATE: N/A. IFU REFERENCE: 090200836 REV. H. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (205513000/PG319561) PRODUCT AND LOT NUMBERS, AND NO NON-CONFORMANCES WERE IDENTIFIED. CORRECTED: H3, H4.

    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.

    Description of Event or Problem · 0

    CUSTOMER IS NOT ABLE TO CLEAN THE INSTRUMENT BEHIND SPRING BALLS. NO ADVERSE PATIENT IMPACT, NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2796058 S/C TRIAL HANDLE ANGLED HIP INSTRUMENTS : HANDLES HWA DEPUY ORTHOPAEDICS INC US 2055-13-000 PG319561 10603295084488

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown