BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE PS FEM TRIAL SZ 6 LT

    MDR report key: 19070014 · Received April 9, 2024

    Report

    Report Number
    1818910-2024-07839
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    January 1, 2024
    Report Date
    April 9, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWT
    UDI-DI
    10603295134084
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY BROKEN AND WORN ATTUNE INSTRUMENTS (CONSIGNED), NEEDING REPLACING THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND BROKEN AT THE CONDYLE, THEREFORE THE REPORT ALLEGATION CAN BE CONFIRMED. THE BROKEN FRAGMENT WAS RETURNED. NO OTHER ISSUES WERE IDENTIFIED. THE FRACTURE SURFACE IS CONSISTENT WITH OVERLOAD DUE TO A COMBINATION OF HEAVY IMPACTION AND THE TRIAL FITTING TOO TIGHT OVER THE POSTERIOR/ANTERIOR ASPECT OF THE RESECTED FEMUR BONE FORCING THE CURVED FEATURES OF THE FEMORAL TRIAL TO OPEN. THE COMBINATION OF HEAVY IMPACTION AND POSSIBLE DISCREPANCIES IN THE RESECTION DEPTH BETWEEN THE FEMUR AND THE TRIAL SUGGEST UNINTENDED USER ERROR. FURTHERMORE, PER THE ATTUNE SURGICAL TECHNIQUE (DSUS/JRC/0316/1437 REV. K) IT IS CAUTIONED WHEN EXTRACTING THE TRIAL, ROCKING THE TRIAL MEDIO-LATERALLY MAY CAUSE CONDYLAR FRACTURE. SUCH ROCKING SHOULD BE AVOIDED. ADDITIONALLY, HEAVY WEAR PATTERNS ON OVERALL DEVICE SURFACE WAS OBSERVED. THE OBSERVED CONDITION WAS IDENTIFIED AS AN END-OF-LIFE INDICATOR, DAMAGE CONSISTENT WITH REPEATED USE AND SERVICING. THE LIFECYCLE REQUIREMENTS OF THE DEVICE ARE EVENT RELATED AND DEPEND ON THE USE AND INSPECTION OF THE DEVICE IN CLINICAL PRACTICE. AS THE DEVICE CAN BE DAMAGED ON THE FIRST OR 100TH USE, THE DEVICE MUST BE PROPERLY INSPECTED PRIOR TO EACH SURGICAL USE. REFER TO THE DEVICE/COUNTRY SPECIFIC IFU FOR INFORMATION RELATED TO END OF LIFE, REPROCESSING INSTRUCTIONS, AND INSPECTION PROCEDURES. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE PS FEM TRIA WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO UNINTENDED USER ERROR, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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). 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. CORRECTED: H3. 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. 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 IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ATTUNE INSTRUMENTS ARE BROKEN AND WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284966 ATTUNE PS FEM TRIAL SZ 6 LT FEMORAL TRIALS HWT DEPUY IRELAND - 9616671 MVMCBH940 10603295134084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown