BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10.5MM REAMER HEAD FOR RIA 2 STERILE

    MDR report key: 10931599 · Received December 2, 2020

    Report

    Report Number
    2939274-2020-05406
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 3, 2020
    Report Date
    November 4, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    PMA / PMN Number
    K111437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. PART 03.404.017S, LOT 6772002: RELEASE TO WAREHOUSE DATE: SEPTEMBER 26, 2019. SUPPLIER: (B)(4). NO NON-CONFORMANCE REPORTS (NCR'S) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: UPON VISUAL INSPECTION, NO PHYSICAL DAMAGE WAS NOTICED. THE DEVICE WAS RECEIVED INTACT. FUNCTIONAL TESTING COULD NOT BE PERFORMED AS MATING SHAFT WAS NOT RETURNED. COMPLAINT WAS UNABLE TO BE REPLICATED. THE COMPLAINT IS NOT CONFIRMED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    UPDATED CONCOMITANT DEVICE: RIA 2 REAMING KIT (PART 03.404.001S, LOT UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN REAMER/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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, DURING AN UNKNOWN PROCEDURE, THE 10MM REAMER HEAD FOR REAMER IRRIGATOR ASPIRATOR (RIA) BROKE FROM THE UNKNOWN REAMER SHAFT. WHILE THE SURGEON WAS REAMING, THE REAMER HEAD APPEARED TO HAVE LOOSENED OFF THE UNKNOWN REAMER SHAFT AND BROKE INSIDE THE INTRAMEDULLARY CANAL OF THE PATIENT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR 1 UNK - REAMERS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397853 10.5MM REAMER HEAD FOR RIA 2 STERILE REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6772002

    Patients

    Seq Age Sex Outcome Treatment
    1 10.0MM REAMER HEAD FOR RIA 2 STERILE| 10.0MM REAMER HEAD FOR RIA 2 STERILE| RIA 2 REAMING KIT 520MM STERILE