BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    MDR report key: 8038460 · Received November 5, 2018

    Report

    Report Number
    2939274-2018-54788
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Report Date
    October 22, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    10886982189042
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE HISTORY LOT PART # 314.743, SYNTHES LOT # H220887, SUPPLIER LOT # H220887, RELEASE TO WAREHOUSE DATE: 16MAY2017; 05JUN2017, SUPPLIER: (B)(4). THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY COMPLAINT SUMMARY: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HEXAGONAL END OF THE REAMER IRRIGATOR ASPIRATOR (RIA) DRIVE SHAFT BROKE INSIDE AN INSTRUMENT WASHER. NO PATIENT INVOLVEMENT. FLOW: BROKEN VISUAL INSPECTION: THE DRIVE SHAFT-MINIMUM OR USE WITH RIA (PART # 314.743, LOT # H220887, MFG # 16 MAY 2017, 05JUN2017) WAS RECEIVED AT US CQ WITH THE DISTAL TIP BROKEN AND THE REMINDER OF THE DISTAL TIP SIGNIFICANTLY DEFORMED. THE BROKEN PORTION OF THE DEVICE WAS NOT RETURNED TO US CQ. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION, THUS CONFIRMING THE COMPLAINT. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS NOT COMPLETED AS THE DISTAL TIP OF THE RIA DRIVE SHAFT IS SIGNIFICANTLY DEFORMED. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WAS REVIEWED; DRIVE SHAFT ASSEMBLY: 314_741 , DRIVE SHAFT: 314_741_1_2 . THE MATERIAL, AND MATERIAL PROPERTIES OF THE RETURNED PART WERE DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE BASED ON REVIEW OF THE DHR. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS THE RIA DRIVE SHAFT (PART # 314.743, LOT # H220887) WAS RECEIVED WITH THE DISTAL TIP OF THE DEVICE BROKEN. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES (SUCH AS BEING DAMAGED DURING STERILE PROCESSING). NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE: (B)(4). REPORTER IS A SYNTHES EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. 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 HEXAGONAL END OF THE REAMER IRRIGATOR ASPIRATOR (RIA) DRIVE SHAFT BROKE INSIDE AN INSTRUMENT WASHER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A DRIVE SHAFT FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879780 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.743 H220887 10886982189042

    Patients

    Seq Age Sex Outcome Treatment
    1