BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI SPIRAL BLADE 90MM FOR TI RETROGRADE FEMORAL NAILS-EX

    MDR report key: 9342485 · Received November 19, 2019

    Report

    Report Number
    2939274-2019-62278
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    November 5, 2019
    Report Date
    November 4, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982087546
    PMA / PMN Number
    K033618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. (B)(4). INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY LOT: PART NUMBER: 04.013.050, LOT NUMBER: 6781134, PART MANUFACTURING DATE: 27 SEPTEMBER 2011, MANUFACTURING SITE: (B)(4), PART EXPIRATION DATE: N/A, NONCONFORMANCE NOTED: NCR # 1041955. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 6781134 OF TI SPIRAL BLADES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL LOT 6650254 WAS OPENED ON NCR # 1041955. THIS NONCONFORMING REPORT WAS OPENED DUE TO OBSERVED DISCOLORATION AT THE ENDS OF SOME RAW MATERIAL BARS. THE NONCONFORMANCE INVESTIGATION DETERMINED THAT THIS CONDITION HAD NO NEGATIVE IMPACT ON THE MATERIAL, AS THE ENDS OF EACH BAR ARE REMOVED DURING PROCESSING WITHOUT BEING INCORPORATED INTO ANY PARTS. THIS NONCONFORMANCE IS DETERMINED NOT TO HAVE ANY RELEVANCE TO THE COMPLAINT CONDITION. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO CHRONIC OSTEOMYELITIS, INFECTION, INFLAMMATION, NONUNION OF JOINT, AND DELAYED HEALING. ONE (1) HINDFOOT NAIL, ONE (1) SPIRAL BLADE, ONE (1) 6MM UNKNOWN LOCKING SCREW, AND ONE (1) 5MM UNKNOWN LOCKING SCREW WERE REMOVED. ALL HARDWARE WAS INTACT. AFTER THE REMOVAL, THE EXTREMITY OF THE PATIENT WAS I&D USING RIA. THERE WAS NO SURGICAL DELAY.  IT IS UNKNOWN IF PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS GOOD. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS IS 4 OF 4 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138898 TI SPIRAL BLADE 90MM FOR TI RETROGRADE FEMORAL NAILS-EX ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.013.050 6781134 10886982087546

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention