BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER HEAD F/RIA 2 Ø10

    MDR report key: 18785271 · Received February 26, 2024

    Report

    Report Number
    8030965-2024-02910
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    February 13, 2024
    Report Date
    February 26, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    UDI-DI
    07612334142382
    PMA / PMN Number
    K993335
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. H10 ADDITIONAL NARRATIVE: D9 H3, H4, H6 INVESTIGATION SUMMARY VISUAL INSPECTION FOUND THE HEAD OF THE REAMER HEAD F/RIA 2 Ø10 BROKEN. ALL PIECES WERE RETURNED FOR EVALUATION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DEVICE WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO USER, 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. DIMENSIONAL INSPECTION: N/A DEVICE HISTORY MANUFACTURING LOCATION: SUPPLIER ¿ MARK TWO ENGINEERING / INSPECTED AND PACKAGED BY: MONUMENT RELEASE TO WAREHOUSE DATE: 09-MAR-2022. EXPIRATION DATE: 01-OCT-2031. PART NUMBER: 03.404.016S, 10MM REAMER HEAD FOR RIA 2-STERILE LOT NUMBER: 447P325 (STERILE) LOT QUANTITY: (B)(4). THIS LOT WAS PROCESSED UNDER JBL-NR-0012368 ISSUED DUE TO AN INCIDENT WHEREIN AN OPERATOR IDENTIFIED THAT THE IPA BOTTLE BEING USED TO CLEAN GLOVES DURING GOWNING WAS FILLED WITH A SUBSTANCE THAT WASN¿T IPA. THE SUBSTANCE WAS ACTUALLY NOVACLEAN WHICH IS USED FOR CLEANING IN THE ROOM. TESTS WERE PERFORMED TO ENSURE THAT REWORK WOULD REMOVE ANY RESIDUE OF THE NOVACLEAN AND RESULTS WERE ACCEPTABLE. ALL PARTS WERE REWORKED AND RELEASED FROM HOLD. PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOGS WERE REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING BOMS WERE REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. SCN 21928 (RECORDED ON REWORK INSTRUCTIONS FORM) SUPPLIED BY STERIGENICS WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART NUMBER: 03.404M016, RIA II REAMER HEAD 10.0MM LOT NUMBER: 123P687 LOT QUANTITY: (B)(4) INSPECTION INSTRUCTION MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF COMPLIANCE RECEIVED FROM MARK TWO ENGINEERING DATED 30-SEP-2021 WAS REVIEWED AND DETERMINED TO BE CONFORMING. CERTIFICATION FOR HEAT TREAT SUPPLIED TO MARK TWO ENGINEERING FROM VACU-BRAZE INC. DATED 23-SEP-2021 WAS REVIEWED AND DETERMINED TO BE CONFORMING. HEAT TREAT SPECIFIED AT 50-55 HRC. RESULTS CERTIFIED AT 51-52 HRC. CERTIFICATE OF ANALYSIS SUPPLIED TO MARK TWO ENGINEERING FROM BANNER MEDICAL DATED 11-SEP-2020 WAS REVIEWED AND DETERMINED TO BE CONFORMING. RAW MATERIAL CERTIFICATION SUPPLIED TO BANNER MEDICAL FROM DUNKIRK SPECIALTY STEEL DATED 13-AUG-2020 WAS REVIEWED AND DETERMINED TO BE CONFORMING. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 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 THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. H3, H6: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NEW ZEALAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON USING RIA 2 SIZE 10MM REAMER HEAD IN A VERY TIGHT HUMERAL CANAL. REAMER HEAD BROKE. SURGEON REMOVED FRAGMENTS. THE SURGERY WAS DELAYED 5 MINUTES BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) REAMER HEAD F/RIA 2 Ø10. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539137 REAMER HEAD F/RIA 2 Ø10 REAMER HTO SYNTHES GMBH 447P325 07612334142382

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male