BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE

    MDR report key: 6440678 · Received March 28, 2017

    Report

    Report Number
    1719045-2017-10262
    Event Type
    Injury
    Date Received
    March 28, 2017
    Report Date
    March 7, 2017
    Manufacturer
    SYNTHES MONUMENT
    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

    (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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). ORIGINAL IMPLANT DATE UNKNOWN MAYBE IN 2016 OR (B)(6) 2017. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(6); MANUFACTURING DATE: 24-JUN-2016; EXPIRATION DATE: 31-MAY-2026. PART #: 04.037.158S, LOT#: H130167 (STERILE)11MM/130 DEG TI CANN TFNA 380MM/RIGHT- STERILE. QUANTITY 6. INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL NS063045 REV: E AND INSPECTION SHEET - TFNA ASSEMBLY INSPECTION NS067861 REV: A MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: 04.037.942.2 - LOCK PRONG 130 DEGREE, TFNA BP-55 LOT - 9951107; 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT - H045933; 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT - H083621; 21127 - RAW MATERIAL LOT BP-80 LOT - H048989. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE 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.

    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.

    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 (B)(6) 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 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222321 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT H130167

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention