BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE PIN PULLER

    MDR report key: 12954138 · Received December 7, 2021

    Report

    Report Number
    1818910-2021-27407
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    November 26, 2021
    Report Date
    November 26, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWB
    UDI-DI
    10603295130574
    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). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED FOR EXAMINATION. THE COMPLAINT CONDITION WAS NOT ABLE TO BE REPLICATED. THE INVESTIGATION CAN NOT CONFIRM THE REPORTED EVENT. 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: PRODUCT DESCRIPTION: ATTUNE PIN PULLER. PRODUCT CODE: 254500060. LOT NUMBER:PG286566. QUANTITY MANUFACTURED: (B)(4). DATE OF MANUFACTURE: 7/15/2019. ANOMALIES/QHF'S FOUND: NONE. IFU REFERENCE: IFU-0902-00-836 REV. G.

    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. 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). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION 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 REPORTS THAT THE INSTRUMENT DOES NOT GRIP PROPERLY ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846953 ATTUNE PIN PULLER ATTUNE INSTRUMENTS : EXTRACTION INSTRUMENTS HWB DEPUY IRELAND - 9616671 2545-00-060 PG286566 10603295130574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown