BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.5MM MEDULLARY REAMER HEAD

    MDR report key: 8465865 · Received March 29, 2019

    Report

    Report Number
    2939274-2019-57179
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Report Date
    March 5, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    10886982194251
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. H10 ADDITIONAL NARRATIVE: H3, H4, H6- SYNREAM REAMER HEAD 12.5 WAS RECEIVED. VISUAL INSPECTION OF THE DEVICE WAS IDENTIFIED TO BE DULL, CONFIRMING THE COMPLAINT CONDITION. FUNCTIONAL TEST WAS PERFORMED AND IDENTIFIED THAT THE FLEXIBLE REAMER SHAFT WAS LOOSE IN COUPLING WITH THE MEDULLARY REAMER HEAD. THE INTERNAL DIAMETER OF THE SYNREAM MEDULLARY REAMER HEAD WAS INTENDED TO BE 4.9 TO 5.0 AND WAS MEASURED TO BE 4.92MM WHICH IS WITHIN SPECIFICATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION CONCLUSION: VISUAL INSPECTION, FUNCTIONAL TEST, DIMENSIONAL INSPECTION AND DOCUMENT REVIEW WERE PERFORMED DURING THE INVESTIGATION. THOUGH DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, REPEATED USE AND SERVICE FOR 15 YEARS MIGHT HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. 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 HISTORY LOT PART: 352.125 LOT: 2100432 (B)(4). RELEASE TO WAREHOUSE DATE: 24. SEP. 2004 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 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. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, AFTER A VISUAL INSPECTION A SYNREAM FLEXIBLE SHAFT TIP WAS NOTICED TO BE WORN AND DAMAGED. THE SYNREAM FLEXIBLE SHAFT WAS TRIED ON DIFFERENT REAMING HEADS AND WAS CONNECTED LOOSELY ON THE SHAFT. THE 12.5MM SYNREAM MEDULLARY REAMER HEAD FIT LOOSELY ON THE ASSEMBLY AND DULL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 12.5MM MEDULLARY REAMER HEAD THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256776 12.5MM MEDULLARY REAMER HEAD REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 352.125 2100432 10886982194251

    Patients

    Seq Age Sex Outcome Treatment
    1