BEUDAMED
    FDA Adverse Event Summary report: N

    RENOVIS

    MDR report key: 6058024 · Received October 26, 2016

    Report

    Report Number
    3007932279-2016-00003
    Date Received
    October 26, 2016
    Date of Event
    September 26, 2016
    Report Date
    October 26, 2016
    Manufacturer
    RENOVIS SURGICAL TECHNOLOGIES
    Product Code
    JWH
    UDI-DI
    00841523102136
    PMA / PMN Number
    K120038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016, DR. (B)(6) INFORMED DR. (B)(4), PRESIDENT AND CEO OF RENOVIS SURGICAL TECHNOLOGIES, VIA ELECTRONIC MAIL THAT A R TIBIAL BASEPLATE CEMENTED KEELED SZ 8 (LOT #2280-6) WAS LABELED INCORRECTLY AS A R TIBIAL BASEPLATE CEMENTED KEELED SZ 6 (LOT #2280-4) AND IMPLANTED INTO A PATIENT. AN INVESTIGATION WAS INITIATED AND MANUFACTURING RECORDS WERE REVIEWED IN ORDER TO DETERMINE HOW THE ERROR OCCURRED. A RE-INSPECTION OF PART # 1202-222-800, LOT #2280-6 WAS PERFORMED BY QC INSPECTOR ((B)(4)) ON 09/27/2016. (B)(4) UNITS FROM LOT 2280-6 WERE FOUND TO BE PACKAGED AND LABELED TO THE CORRECT SPECIFICATIONS. ONE UNIT LABELED A R TIBIAL BASEPLATE CEMENTED KEELED SIZE 8, P/N 1202-222-800, LOT #2280-6 WAS IN FACT, A R TIBIAL BASEPLATE CEMENTED KEELED SIZE 6, P/N 1202-222-600 FROM LOT #2280-4. THE SIZE AND LOT MARKINGS ON THE PHYSICAL DEVICE DID NOT MATCH THE INFORMATION ON THE LABELING. IT WAS DETERMINED THAT THE ERROR OCCURRED DURING THE PACKAGING PROCESS. PACKAGING SUBCONTRACTOR ((B)(4)) WAS CONTACTED REGARDING THE NON-CONFORMANCE AND INITIATED AN INTERNAL INVESTIGATION. THROUGH THEIR INVESTIGATION IT WAS DETERMINED THAT THE MIX-UP OCCURRED DURING THE TOC EXTRACTION PROCESS. ONE UNIT OF EACH LOT BEING PACKAGED IS REMOVED AND PLACED INTO SEPARATE BEAKERS IN THE TOC EXTRACTION AREA. THE TOC EXTRACTION IS PERFORMED AND THE PARTS ARE THEN INDIVIDUALLY PLACED INTO A PRIMARY STERILE BARRIER (POUCH) AND RETURNED TO THE PRODUCT GROUP FROM WHICH THEY WERE REMOVED. IT WAS DURING THIS STEP THAT THE PARTS WERE RETURNED TO THE INCORRECT GROUP. (B)(4) IS IMPLEMENTING A SECOND PART # / LOT# VERIFICATION STEP AFTER TOC EXTRACTION IN ORDER TO PREVENT THE SAME TYPE OF ERROR FROM OCCURRING IN THE FUTURE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, DR. (B)(6) INFORMED DR. (B)(4), PRESIDENT AND CEO OF RENOVIS SURGICAL TECHNOLOGIES, VIA ELECTRONIC MAIL THAT A R TIBIAL BASEPLATE CEMENTED KEELED SZ 8 (LOT #2280-6) WAS LABELED INCORRECTLY AS A R TIBIAL BASEPLATE CEMENTED KEELED SZ 6 (LOT #2280-4) AND IMPLANTED INTO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707867 RENOVIS TIBIAL BASEPLATE CEMENTED KEELED JWH RENOVIS SURGICAL TECHNOLOGIES A200 2280-4 00841523102136

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR