BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIRAL BLADE F/EXPERT RFN L75 TAN GOLD

    MDR report key: 7176615 · Received January 9, 2018

    Report

    Report Number
    2939274-2018-50139
    Event Type
    Injury
    Date Received
    January 9, 2018
    Report Date
    December 13, 2017
    Manufacturer
    WRIGHTS LANE: SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982087485
    PMA / PMN Number
    K033618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. DATE OF EVENT: IT IS UNKNOWN WHEN THE EVENT OCCURRED. ADDITIONAL PROCODE HWC. PRODUCT INVESTIGATION HAS NOT BEEN COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE AND IT'S SUB COMPONENTS THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. NO NCRS WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. 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

    ADD'L NARRATIVE: PATIENT WEIGHT REPORTED AS (B)(6) IT IS UNKNOWN IF THAT IS (B)(6) POUNDS OR KILOGRAMS. PART 04.013.047, LOT H052871: DATE OF MANUFACTURE: MARCH 02, 2016. PLACE OF MANUFACTURE: (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TI SPIRAL BLADE 75MM FOR TI RETROGRADE FEMORAL NAILS ¿ EX NONSTERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL 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. CORRECTED DATA: INITIALLY REPORTED AS (B)(6) 2017 BUT SHOULD HAVE BEEN (B)(6) 2017. 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 HINDFOOT NAIL WAS IMPLANTED ON (B)(6) 2017 IN A DIABETIC PATIENT. EVENTUALLY SKIN NECROSED OVER SPIRAL BLADE SITE AND HARDWARE WAS EXPOSED. SO A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 TO REMOVE THE BLADE AND THE WOUND WAS TREATED WITH A VACUUM-ASSISTED CLOSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY AND THE PATIENT WAS STABLE AFTER THE SURGERY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR A HELICAL BLADE. THIS IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18079 SPIRAL BLADE F/EXPERT RFN L75 TAN GOLD ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 04.013.047 H052871 10886982087485

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention