BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S/C TRIAL HANDLE ANGLED

    MDR report key: 14495926 · Received May 25, 2022

    Report

    Report Number
    1818910-2022-09607
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    May 1, 2022
    Report Date
    May 25, 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

    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.

    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: D9. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CORRECTED: H3.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY VISUAL EXAMINATION OF THE RETURNED DEVICE CAN CONFIRM THE REPORTED ALLEGATION. FOREIGN SUBSTANCE WAS FOUND ON THE DEVICE SPRING BALLS AND OVERALL, THE DEVICE PRESENTS VISIBLE STAINS. THE REPORTED CONDITION WAS CONFIRMED. 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. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. DEVICE HISTORY LOT PRODUCT DESCRIPTION: S/C TRIAL HANDLE ANGLED PRODUCT CODE: 205513000. LOT NUMBER: PG312859. PLEASE PROVIDE: 1) QUANTITY MANUFACTURED: 51. 2) DATE OF MANUFACTURE: 07/28/2021. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: ONE QHF WAS FOUND AT THE ASSEMBLY OP FOR PASSIVATION STAINS ON SHAFT. 4) EXPIRY DATE: N/A. 5) IFU REFERENCE: (B)(4). REV. K CORRECTED: H3, H4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER IS NOT ABLE TO CLEAN THE INSTRUMENT BEHIND SPRING BALLS. NO ADVERSE PATIENT IMPACT, NO SURGICAL DELAY. SEEN IN CSSD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697766 S/C TRIAL HANDLE ANGLED HIP INSTRUMENTS : HANDLES HWA DEPUY ORTHOPAEDICS INC US 2055-13-000 PG312859 10603295084488

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown