BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15.0MM REAMER HEAD FOR RIA 2 STERILE

    MDR report key: 12032070 · Received June 21, 2021

    Report

    Report Number
    2939274-2021-03078
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Report Date
    May 20, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRX
    UDI-DI
    10886982273956
    PMA / PMN Number
    K111437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H7 H9: 3008812560-10/26/2020-001-C. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY (CQ) SHOWED THE FOUR PRONGS OF THE 15.0MM REAMER HEAD FOR RIA 2 STERILE (PART #03.404.026S; LOT # UNK) HAVE BROKEN OFF. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST MANUFACTURED DAMAGE AND AN ACCURATE DIMENSIONAL INSPECTION COULD NOT BE OBTAINED DUE TO BROKEN CONDITION OF THE PRONGS. DOCUMENT/SPECIFICATION REVIEW: THE RELEVANT CURRENT DRAWING WAS REVIEWED: AS THE LOT NUMBER WAS UNKNOWN, NO MANUFACTURING DRAWING COULD BE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED ON THE REVIEW OF THE CURRENT DRAWING. CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE COMPLAINT DEVICE WAS RECEIVED WITH ALL ITS FOUR PRONGS BROKEN OFF. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED BASED ON THE PROVIDED INFORMATION. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DUE TO THE TREND WITH THE BROKEN RIA 2 REAMER HEADS IDENTIFIED DURING POST MARKET SURVEILLANCE, CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS RAISED TO DETERMINE THE ROOT CAUSE OF BROKEN HEAD BREAKAGES. ADDITIONALLY, THE FIELD SAFETY NOTICE FSN 1882308 AND PIE WERE INITIATED TO DEFINE ANY FURTHER ACTION RELATED TO THE BREAKAGE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A MRE REVIEW COULD NOT BE PERFORMED. IF MORE INFORMATION BECOME AVAILABLE, THE RECORD WILL BE RE-ASSESSED. 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

    REPORTER IS A SYNTHES EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 AN UNKNOWN DATE, THE 15.0MM REAMER HEAD FOR RIA 2 STERILE WAS RECEIVED BROKEN. THIS REPORT IS FOR ONE (1) 15.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929586 15.0MM REAMER HEAD FOR RIA 2 STERILE ARTHROSCOPE HRX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.404.026S 10886982273956

    Patients

    Seq Age Sex Outcome Treatment
    1