BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE

    MDR report key: 7454232 · Received April 24, 2018

    Report

    Report Number
    2939274-2018-51875
    Event Type
    Injury
    Date Received
    April 24, 2018
    Report Date
    April 4, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982226990
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: HWC. DATE OF IMPLANT IS AN UNKNOWN DATE IN 2016. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PATIENT CODE (B)(4) USED TO CAPTURE ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 456.325, LOT# 9883745. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: AUG 25, 2015, EXPIRY DATE: JUL 31, 2024. COMPONENT PARTS REVIEWED: 456.314.3 - LOCK DRIVER TFN, BP-55 LOT ¿ 7872093. 456.315.2 - 130 DEGREE LOCK PRONG TFN BP-58 LOT ¿ 9860457. 21069 - RAW MATERIAL LOT BP-80 LOT - 7989996. RAW MATERIAL FOR (B)(4) WAS RECEIVED FROM (B)(4). CERTIFIED TEST REPORT AND CERTIFICATE OF TEST FOR (B)(4) INGOT RECEIVED FROM (B)(4) MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. NO NON- CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THE PATIENT WAS IMPLANTED WITH A TROCHANTERIC FEMORAL NAIL (TFN) IN 2016. THE PATIENT SUFFERED FROM VARIOUS ILLNESS AND IS ADVANCED IN AGE. DUE TO INFECTION, THE PATIENT UNDERWENT A REMOVAL SURGERY ON (B)(6) 2018. IT WAS REPORTED THAT THE TFN NAIL, HELICAL BLADE AND A 5.0 LOCKING SCREW WERE REMOVED AND NOTHING WAS REPLACED. IT WAS ALSO REPORTED THAT AT THE END OF THE PROCEDURE THERE WAS A COMPLETE IRRIGATION OF THE INFECTED AREA WHICH WAS THE ENTIRE LEFT LEG OF THE PATIENT. THERE WERE LABORATORY CULTURE TESTS TAKEN DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297269 10MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 456.325S 9883745 10886982226990

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention