BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16.0MM REAMER HEAD FOR RIA 2 STERILE

    MDR report key: 13577518 · Received February 22, 2022

    Report

    Report Number
    8030965-2022-01034
    Event Type
    Injury
    Date Received
    February 22, 2022
    Date of Event
    February 7, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    UDI-DI
    07612334142504
    PMA / PMN Number
    K111437
    Removal / Correction Number
    Z-0583-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DEVICE PRODUCT CODES: HRX. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. MANUFACTURING LOCATION: SUPPLIER ¿ (B)(4) / INSPECTED AND PACKAGED BY: (B)(4). RELEASE TO WAREHOUSE DATE: 31-JAN-2020 EXPIRATION DATE: 01-JAN-2030 PART NUMBER: 03.404.028S, 16.0MM REAMER HEAD FOR RIA 2-STERILE LOT NUMBER: 38P4643 (STERILE) PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) LMD REV AA WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. 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: 03.404M028, RIA 2 REAMER HEAD 16.0MM LOT NUMBER: 6772013 LOT QUANTITY: (B)(4). INSPECTION INSTRUCTION MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF COMPLIANCE WAS REVIEWED AND DETERMINED TO BE CONFORMING. CERTIFICATION FOR HEAT TREAT WAS REVIEWED AND DETERMINED TO BE CONFORMING. CERTIFICATE OF ANALYSIS WAS REVIEWED AND DETERMINED TO BE CONFORMING. MATERIAL CERTIFICATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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.

    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. H3, H6: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE REAMER HEAD F/RIA 2 Ø15 WAS FOUND THE DEVICE BROKEN FROM THE TIP. ADDITIONALLY CORROSION WAS OBSERVE ON THE DEVICE. NO EVIDENCE OF AN EMBEDDED DEVICE WAS PROVIDED. A DIMENSIONAL INSPECTION FOR THE REAMER HEAD F/RIA 2 Ø16 WAS UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE CONFIRMED WOULD, CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. DUE TO THE TREND WITH THE BROKEN REAMER HEAD F/RIA 2 Ø16 IDENTIFIED DURING POST-MARKET SURVEILLANCE, RELEVANT ACTIONS HAVE BEEN TAKEN TO ADDRESS THE ISSUE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. *********************************************** DRAWING/SPECIFICATIONS REVIEWED: THE DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. 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. 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 (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE USE OF RAI 2 SYSTEM IN THE ORTHOPEDIC OPERATING ROOM, WHEN REMOVING THE DEVICE, THE REAMER HEADS BROKE AT THE LEVEL OF THE BLADE CUTTING EDGES. THIS HAPPENED FOR ALL THREE REAMER HEADS USED. THE PROCEDURE WENT WELL WITH NO CONSEQUENCES FOR THE PATIENT, BUT THE BROKEN PIECES OF THE REAMER HEADS COULD NOT BE RECOVERED AND REMAINED IN THE PATIENT. THERE WAS A SURGICAL DELAY OF APPROXIMATELY THIRTY (30) MINUTES. THIS REPORT INVOLVES ONE (1) 16.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004706 16.0MM REAMER HEAD FOR RIA 2 STERILE REAMER HTO SYNTHES GMBH 38P4643 07612334142504

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention REAMER HEAD F/RIA 2 Ø15.| REAMER HEAD F/RIA 2 Ø16.5.| RIA 2 BONE HARVESTING KIT L520.| SYNREAM REAMING ROD Ø2.5 SHORT L950.