BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7939748 · Received October 5, 2018

    Report

    Report Number
    2939274-2018-54192
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Report Date
    September 13, 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
    GA, 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. H10 ADDITIONAL NARRATIVE: H3, H6: PART: 314.743; SYNTHES LOT: 9961622; SUPPLIER LOT: 9961622; RELEASE TO WAREHOUSE DATE: MARCH 09, 2016; MANUFACTURED BY CRITERION TOOL & DIE, INC. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING MANUFACTURING. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. FLOW: BROKEN. VISUAL INSPECTION: THE REAMER/IRRIGATOR/ASPIRATOR (RIA) DRIVE SHAFT WAS RECEIVED AT US CQ WITH THE DISTAL TIP OF THE DRIVE SHAFT BROKEN. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION, THUS CONFIRMING THE COMPLAINT. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS COMPLETED, THE INNER DIAMETER OF THE DRIVE SHAFT AT THE FRACTURE SITE MEASURED 3.74 MM. THIS IS WITHIN SPECIFICATION OF 3.76 MM ± 0.05, BASED ON DEVICE DRAWING. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWINGS WERE REVIEWED; DRIVE SHAFT ASSEMBLY; DRIVE SHAFT RIA. DEVICE HISTORY RECORD (DHR) REVIEW SHOWED NO NCRS WERE GENERATED DURING PRODUCTION. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS THE RIA DRIVE SHAFT WAS RECEIVED WITH THE DISTAL TIP OF THE SHAFT 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. 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. 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

    ADDITIONAL PRODUCT CODE: HRX. INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. 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, A REAMER IRRIGATOR ASPIRATOR DRIVE SHAFT BROKE DURING DISASSEMBLY AFTER AN ORTHOPEDIC PROCEDURE. FINAL IMAGES TAKEN AT CONCLUSION OF CASE SHOWED NO METAL FRAGMENTS WERE LEFT IN THE PATIENT. THERE IS NO REPORTED PATIENT CONSEQUENCE. 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
    781427 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.743 9961622 10886982189042

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR