BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINN POLY IMPACTOR TIP 36MM

    MDR report key: 8646700 · Received May 28, 2019

    Report

    Report Number
    1818910-2019-94604
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    May 10, 2019
    Report Date
    May 10, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HWA
    UDI-DI
    10603295098973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. 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

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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: CORRECTED: DEVICE EVALUATED BY MFR PRODUCT COMPLAINT # ==> (B)(4). INVESTIGATION SUMMARY ==> EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT. DEPUY 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. 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 WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (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

    PRIOR TO SURGERY ON (B)(6), THE SURGICAL TECH SHOWED ME THREE INSTRUMENTS THAT SEEMED TO BE DAMAGED. ONE BEING A T-HANDLE: WHICH HAD A CRACK IN THE HANDLE PORTION. THE SECOND, WAS A 36 LINER IMPACTOR. WHICH WAS SCRAPED AND HAD OBVIOUS SIGNS OF WEAR AND TEAR. THE THIRD, WAS A CHANA HANDLE SET. IT WAS NOT ENGAGING PROPERLY WITH THE HOSPITALS SYSTEM 7. NEITHER WERE USED IN SURGERY. OUR OFFICE ALREADY ORDERED NEW INSTRUMENTS SO THEY CAN BE REPLACED THIS IS ALL THE INFORMATION I CAN PROVIDE. PATIENT STATUS/OUTCOME/CONSEQUENCES: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440897 PINN POLY IMPACTOR TIP 36MM HIP INSTRUMENTS : INSERTION DEVICES HWA DEPUY ORTHOPAEDICS, INC. 1818910 HT0307 10603295098973

    Patients

    Seq Age Sex Outcome Treatment
    1