BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE REV FEM CTT TRL SZ 6 R

    MDR report key: 18309495 · Received December 12, 2023

    Report

    Report Number
    1818910-2023-25174
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    December 1, 2023
    Report Date
    December 12, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295439790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY : DIRTY INSTRUMENT IN THE ATTUNE CORE INSTRUMENTS TRAY. SEE ATTACHED THE PICTURE. ¿THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT [DPBE23-097]. THE PHOTO ANALYSIS REVEALED THAT THE DEVICE HAS SIGNS OF SOME FOREIGN SUBSTANCE ON IT. THE EVIDENCE PROVIDED SUGGEST THAT THE UNCLEAN CONDITION IS DUE TO CLEANING PROCESS AND MISSED INSPECTION AT THE THIRD-PARTY LOGISTICS SITE BEFORE BEING SHIPPED TO THE HOSPITAL. A DELIVERY SERVICE ISSUE AND QUALITY ISSUE RECORD WERE RAISED AND INVESTIGATED BY THE RESPONSIBLE PARTY IN THEIR QUALITY SYSTEM. THE REPORTED ALLEGATION CAN BE CONFIRMED. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. ¿THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE UNK FEMORAL TRIAL WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE IS TRACED TO MAINTENANCE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT:A NR WAS CREATED TO THE 3RD-PARTY LOGISTICS SITE TO ADDRESS THE REPORTED CONDITION. THE CREATED NR IS NOT RELATED TO DEPUY SYNTHES PRODUCT NONCONFORMANCE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY- DIRTY INSTRUMENT IN THE ATTUNE CORE INSTRUMENTS TRAY. SEE ATTACHED THE PICTURE. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT [DPBE23-097]. THE PHOTO ANALYSIS REVEALED THAT THE DEVICE HAS SIGNS OF SOME FOREIGN SUBSTANCE ON IT. THE EVIDENCE PROVIDED SUGGEST THAT THE UNCLEAN CONDITION IS DUE TO CLEANING PROCESS AND MISSED INSPECTION AT THE THIRD-PARTY LOGISTICS SITE BEFORE BEING SHIPPED TO THE HOSPITAL. A DELIVERY SERVICE ISSUE AND QUALITY ISSUE RECORD WERE RAISED AND INVESTIGATED BY THE RESPONSIBLE PARTY IN THEIR QUALITY SYSTEM. THE REPORTED ALLEGATION CAN BE CONFIRMED. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE REV FEM CTT TRL SZ 6 R WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE IS TRACED TO MAINTENANCE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: DIRTY INSTRUMENT IN THE ATTUNE CORE INSTRUMENTS TRAY. SEE ATTACHED THE PICTURE. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT [(B)(6)]. THE PHOTO ANALYSIS REVEALED THAT THE DEVICE HAS SIGNS OF SOME FOREIGN SUBSTANCE ON IT. THE EVIDENCE PROVIDED SUGGEST THAT THE UNCLEAN CONDITION IS DUE TO CLEANING PROCESS AND MISSED INSPECTION AT THE THIRD-PARTY LOGISTICS SITE BEFORE BEING SHIPPED TO THE HOSPITAL. A DELIVERY SERVICE ISSUE AND QUALITY ISSUE RECORD WERE RAISED AND INVESTIGATED BY THE RESPONSIBLE PARTY IN THEIR QUALITY SYSTEM. THE REPORTED ALLEGATION CAN BE CONFIRMED. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE UNK FEMORAL TRIAL WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE IS TRACED TO MAINTENANCE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A NR WAS CREATED TO THE 3RD-PARTY LOGISTICS SITE TO ADDRESS THE REPORTED CONDITION. THE CREATED NR IS NOT RELATED TO DEPUY SYNTHES PRODUCT NONCONFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE DIRTY INSTRUMENTS IN THE ATTUNE CORE INSTRUMENTS TRAY. THIS HAPPENED AT 3PL AND ACCORDINGLY QUALITY ISSUE HAS BEEN SET UP IN ETQ NR-0210271. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694622 ATTUNE REV FEM CTT TRL SZ 6 R FEMORAL TRIALS LXH DEPUY ORTHOPAEDICS INC US 10603295439790
    2185852 ATTUNE REV FEM CTT TRL SZ 6 R FEMORAL TRIALS LXH DEPUY ORTHOPAEDICS INC US 10603295439790
    295181 ATTUNE REV FEM CTT TRL SZ 6 R FEMORAL TRIALS LXH DEPUY ORTHOPAEDICS INC US 10603295439790

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown