BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8703847 · Received June 17, 2019

    Report

    Report Number
    2939274-2019-58690
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Report Date
    May 20, 2019
    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
    FL, 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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 314.743, SYNTHES LOT # H220886, SUPPLIER LOT # H220886, RELEASE TO WAREHOUSE DATE: 12 AUG 2017, SUPPLIER: (B)(4). THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. NO 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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE DRIVE SHAFT WAS RECEIVED AT US CQ WITH THE DISTAL TIP OF THE DEVICE BROKEN. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION, THUS CONFIRMING THE COMPLAINT. DIMENSIONAL INSPECTION:THE SHAFT INSIDE DIAMETER JUST PROXIMAL TO THE BROKEN DISTAL TIP MEASURED AND IS WITHIN SPECIFICATION PER RELEVANT DRAWING. DOCUMENT/SPECIFICATION REVIEW: A REVIEW OF MANUFACTURING EVALUATION RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CONCLUSION: 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. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE INSPECTING THE INSTRUMENTS AFTER COMING OUT OF THE DECONTAMINATION PROCESS, IT WAS NOTICED THAT THE DRIVESHAFT FOR USE WITH REAMER/ IRRIGATOR/ ASPIRATOR (RIA) WAS BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499591 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.743 H220886 10886982189042

    Patients

    Seq Age Sex Outcome Treatment
    1