BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10.0MM REAMER HEAD FOR RIA 2 STERILE

    MDR report key: 12919596 · Received December 2, 2021

    Report

    Report Number
    8030965-2021-09919
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    November 4, 2021
    Report Date
    November 4, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    UDI-DI
    07612334142382
    PMA / PMN Number
    K111437
    Removal / Correction Number
    Z-0571-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: MANUFACTURING LOCATION: (B)(4). RELEASE TO WAREHOUSE DATE: 28-DEC-2020. EXPIRATION DATE: 01-DEC-2030. PART NUMBER: 03.404.016S, 10.0MM REAMER HEAD FOR RIA 2-STERILE. LOT NUMBER: 80P5152 (STERILE). LOT QUANTITY: 50. PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) LMD WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. SCN WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL 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: 03.404.M016, RIA 2 REAMER HEAD 10.0MM. LOT NUMBER: 6954001. LOT QUANTITY: 292. INSPECTION INSTRUCTION MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF COMPLIANCE DATED (B)(6) 2020 WAS REVIEWED AND DETERMINED TO BE CONFORMING. CERTIFICATION FOR HEAT TREAT DATED (B)(6) 2020 WAS REVIEWED AND DETERMINED TO BE CONFORMING. RAW MATERIAL CERTIFICATION DATED (B)(6) 2020 WAS REVIEWED AND DETERMINED TO BE CONFORMING. RAW MATERIAL CERTIFICATE OF TESTS DATED (B)(6) 2019 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. 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 (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, A SURGEON PERFORMED THE REAMING OF FEMUR FOR GRAFT COLLECTION USING REAMER/IRRIGATOR/ASPIRATOR (RIA) 2. SURGEON STARTED WITH A 10MM REAMER HEAD. HE ADVANCED THE REAMER DOWN TO THE KNEE AND WHEN PULLING THE REAMER OUT, THE METAL FRAGMENTS WERE NOTICED ON THE X-RAY. REAMER HEAD HAD DISENGAGED, AND THE FOUR (4) PRONGS HAD BROKEN OFF. THREE (3) OF THE FOUR (4) FRAGMENTS REMOVED WITH SUBSEQUENT REAMING BUT 1 FRAGMENT LEFT IN PATIENT. SURGEON REMOVED REAMER HEAD WITH BALL TIP WIRE AND OPENED NEW REAMER HEAD SIZE 12 AND CONTINUED REAMING. THERE WERE NO FURTHER PROBLEMS WITH THE REAMER HEADS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 10.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813925 10.0MM REAMER HEAD FOR RIA 2 STERILE REAMER HTO SYNTHES GMBH 80P5152 07612334142382

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention UNK - REAMERS| UNK - REAMING RODS