BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE NOTCH GUIDE SZ 4

    MDR report key: 16102038 · Received January 5, 2023

    Report

    Report Number
    1818910-2023-00470
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    January 1, 2022
    Report Date
    January 5, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HTZ
    UDI-DI
    10603295130413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 TO DEPUY SYNTHES FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE CONFIRMED THE REPORTED ALLEGATION. THE DEVICE PRESENTS AN OVERALL APPEARANCE OF HEAVY USAGE, AND THE WHITE MARKINGS ON THE DEVICE'S SURFACE WERE WORN OUT. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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

    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:  IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CORRECTED: E1 (COUNTRY CODE).

    Description of Event or Problem · 0

    IT WAS REPORTED THE ATTUNE INSTRUMENTS IS DAMAGED AFTER CLEANING. OCCURRED AFTER CLEANING. NO ADVERSE AFFECTS ON THE PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTRUMENT WAS WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724653 ATTUNE NOTCH GUIDE SZ 4 ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES HTZ DEPUY IRELAND - 9616671 2545-00-024 PG280515 10603295130413

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown