BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER

    MDR report key: 7175069 · Received January 9, 2018

    Report

    Report Number
    2939274-2018-50123
    Event Type
    Injury
    Date Received
    January 9, 2018
    Report Date
    December 12, 2017
    Manufacturer
    WRIGHTS LANE: SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982227317
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. IT IS UNKNOWN WHEN THE EVENT OCCURRED. (B)(4). 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

    DEVICE HISTORY RECORDS (DHR) REVIEW WAS COMPLETED FOR PART# 456.359S, LOT# 6278678. MANUFACTURING LOCATION: (B)(4) , MANUFACTURING DATE: DEC 16, 2009, EXPIRATION DATE: NOV 30, 2018. 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. IN-PROCESS INSPECTION SHEET, IN-PROCESS/INSPECT DIMENSIONAL, AND FINAL INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: 456.314.3 - LOCK DRIVER TFN, BP-55 LOT ¿ 6162656; 456.315.2 - 130 DEGREE LOCK PRONG TFN BP-58 LOT - 6205461 21069 - RAW MATERIAL LOT BP-80 LOT ¿ 6136151 MET SPECIFICATIONS. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.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 A HARDWARE REMOVAL AND REVISION WAS PERFORMED ON (B)(6) 2017. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A TROCHANTERIC FIXATION NAIL, HELICAL BLADE, AND UNKNOWN SCREWS ON A UNKNOWN DATE. THE PATIENT SUBSEQUENTLY EXPERIENCED A NON-UNION AND THESE PARTS WERE REMOVED. THE REMOVED DEVICES WERE INTACT. THE PATIENT WAS REVISED TO A PLATE. THERE WAS NO SURGICAL DELAY. NO INFORMATION REGARDING THE PATIENT STATUS AS WELL THE PROCEDURE STATUS WAS PROVIDED. THIS COMPLAINT INVOLVES THREE (3) PARTS. THIS REPORT IS FOR A NAIL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18825 10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 456.359S 6278678 10886982227317

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention