BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA SCREW 90MM - STERILE

    MDR report key: 6440732 · Received March 28, 2017

    Report

    Report Number
    3003506883-2017-10046
    Event Type
    Injury
    Date Received
    March 28, 2017
    Report Date
    March 7, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: EVENT DATE: UNKNOWN. (B)(4). ORIGINAL IMPLANT DATE UNKNOWN MAY BE 2016 OR (B)(6) 2017. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. ORIGINAL IMPLANT DATE UNKNOWN MAY BE 2016 OR (B)(6) 2017 . THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. SHOULD FURTHER INFORMATION BECOME AVAILABLE THIS DETERMINATION WILL BE REVIEWED ACCORDINGLY. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART # 04.038.090S, LOT # 9841586, RELEASE TO WAREHOUSE DATE: 28 JULY 2015, EXPIRATION DATE: 30 JUNE 2025, MANUFACTURING SITE: (B)(6). DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA SCREW 90MM STERILE 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. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    (B)(6). 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 PATIENT UNDERWENT THE REMOVAL OF A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL AND LAG SCREW AND WAS REVISED TO A DEPUY TOTAL HIP ON (B)(6) 2017. THE PATIENT HAD INITIALLY BEEN IMPLANTED WITH THE TFNA NAIL AND LAG SCREW IN EITHER DECEMBER 2016 OR (B)(6) 2017 AND HAD FALLEN ON AN UNKNOWN DATE. AN X-RAY, DATE UNKNOWN, REVEALED THAT THE FRACTURE WAS IN THE FEMORAL HEAD AND THAT THE NAIL HAD PULLED OUT OF PLACE. IT WAS REPORTED THAT BOTH DEVICES WERE INTACT AND EASILY REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY, AND THE PATIENT REPORTED AS STABLE. THIS COMPLAINT IS FOR TWO DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    CLARIFICATION WAS RECEIVED THAT IT WAS THE LAG SCREW THAT HAD PULLED OUT OF PLACE NOT THE NAIL AS PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223032 TFNA SCREW 90MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA 9841586

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention