BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.5MM REAMER HEAD FOR RIA 2 STERILE

    MDR report key: 10152707 · Received June 15, 2020

    Report

    Report Number
    2939274-2020-02794
    Event Type
    Injury
    Date Received
    June 15, 2020
    Date of Event
    June 2, 2020
    Report Date
    June 2, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    10886982273970
    PMA / PMN Number
    K111437
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: MANUFACTURING LOCATION: SUPPLIER ¿ MARK TWO ENGINEERING / INSPECTED AND PACKAGED BY: MONUMENT RELEASE TO WAREHOUSE DATE: 12-DEC-2019. EXPIRATION DATE: 31-OCT-2029. PART NUMBER: 03.404.019S, 11.5MM REAMER HEAD FOR RIA 2-STERILE. LOT NUMBER: 29P3334 (STERILE). LOT QUANTITY: 49. ONE PIECE WAS SCRAPPED IN CELL, PREP/SEAL ORDER AFTER BEING DROPPED. PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE ONE PIECE NOTED. PACKAGING LABEL LOG (PLL) LPPF REV A, LMD REV A 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, 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: 03.404.M019, LOT NUMBER: 6772004, LOT QUANTITY: 302. INSPECTION INSTRUCTION MET ALL INSPECTION ACCEPTANCE CRITERIA. 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. 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 · 1

    ADDITIONAL DEVICE PRODUCT CODES: HRX.. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. 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 · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE FOR POLY TRAUMA INCLUDING BILATERAL FEMUR FRACTURES. DURING THE PROCEDURE, THE HEAD OF A REAMER HEAD FOR REAMER IRRIGATOR ASPIRATOR (RIA2) SNAPPED OFF IN THE 1 CANAL WHILE TRYING TO BRING THE RIA BACK OUT AFTER REAMING. THE HEAD WAS RETRIEVED, AND A SMALL COUPLE OF PIECES REMAINED IN THE CANAL. THE SURGEON ATTEMPTED TO REAM THE SECOND FEMUR WITH ANOTHER REAMER HEAD FOR REAMER IRRIGATOR ASPIRATOR (RIA2), BUT THE TIP SNAPPED IN THE CANAL ALSO, AND STARTED TO BACK IT UP TO CLEAR A BUTTERFLY FRAGMENT THAT WAS IMPEDING THE INSERTION OF THE REAMER. THE HEAD OF THE SECOND REAMER HEAD FOR REAMER IRRIGATOR ASPIRATOR (RIA2 WAS ALSO RETRIEVED. THE FLEXIBLE REAMERS WERE USED FOR BACK-UP. THE CASE COMPLETED SUCCESSFULLY, AND THERE WAS A FIFTEEN (15) MINUTE DELAY BETWEEN THE TWO SIDES. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 12.0MM REAMER HEAD FOR RIA 2 STERILE (PART NUMBER 03.404.020S, LOT 30P7600, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 11.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617978 11.5MM REAMER HEAD FOR RIA 2 STERILE REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.404.019S 29P3334 10886982273970

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention 12.0MM REAMER HEAD FOR RIA 2 STERILE| 12.0MM REAMER HEAD FOR RIA 2 STERILE