BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8893668 · Received August 14, 2019

    Report

    Report Number
    2939274-2019-59821
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Date of Event
    July 17, 2019
    Report Date
    July 17, 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
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODES: NBH, HRX. PART: 314.743, SYNTHES LOT: 7432393, SUPPLIER LOT: N/A; RELEASE TO WAREHOUSE DATE: APRIL 07, 2014, EXPIRATION DATE: N/A, SUPPLIER: (B)(4) INC. NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE DRIVE SHAFT- MINIMUM 520 MM LENGTH-FOR USE WITH RIA WAS RECEIVED WITH THE COUPLER DISTAL TIP BROKEN OFF. THE BROKEN OFF DISTAL TIP FRAGMENT(S) WERE NOT RECEIVED AND ARE MISSING. THE SHAFT WAS ALSO OBSERVED TO BE SLIGHTLY BENT. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. THE DEVICE FAILURE/DEFECT OF BROKEN TIP AND BENT SHAFT WAS IDENTIFIED DURING THE INVESTIGATION AND IS RELATED TO THE REPORTED COMPLAINT CONDITION, AS IT IS LIKELY THE SHAFT BENT THEN BROKE AT THE TIP. DIMENSIONAL INSPECTION: FEATURES: CROSS SECTION B-B DRIVE SHAFT OUTER DIAMETER AND INNER DIAMETER (CANNULATION) RESULT: BOTH THE OUTER DIAMETER AND INNER DIAMETER MEASUREMENTS ARE CONFORMING DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED. DRIVE SHAFT ASSEMBLY RIA, DRIVE SHAFT RIA. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE DRIVE SHAFT-MINIMUM 520 MM LENGTH-FOR USE WITH RIA AS THE COUPLER DISTAL TIP WAS BROKEN OFF. THE BROKEN OFF DISTAL TIP FRAGMENT(S) WERE NOT RECEIVED AND ARE MISSING. THE SHAFT WAS ALSO OBSERVED TO BE SLIGHTLY BENT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED / EXCESSIVE FORCES AND / OR ROUGH HANDLING DURING DEVICE USE, CAUSING BENDING THEN BREAKAGE. DURING THIS INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019, WHILE THE SURGEON WAS REAMING THE CANAL OF THE FEMUR TO GET SOME BONE GRAFT, THE REAMER DRIVE SHAFT SNAPPED AND WAS MAKING A STRANGE NOISE. THE SURGEON WENT THROUGH THE DRIVE SHAFT INTO ASSEMBLY FROM THE FEMUR OF THE PATIENT AND IT WAS DISCOVERED THE DRIVE SHAFT ITSELF HAD SHEARED OFF. THE DRIVE SHAFT WAS PUT ASIDE. A SECONDARY DRIVE SHAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO FRAGMENTS GENERATED FROM THE BREAKAGE OF THE DEVICE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN TEN (10) MINUTES. THERE WAS NO HARM TO THE PATIENT. CONCOMITANT DEVICES: REAMER HEAD (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A DRIVE SHAFT-MINIMUM 520 MM 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
    686977 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.743 7432393 10886982189042

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR