BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TFNA 360MM/LEFT ¿ STERILE

    MDR report key: 6740615 · Received July 25, 2017

    Report

    Report Number
    1719045-2017-10690
    Event Type
    Injury
    Date Received
    July 25, 2017
    Report Date
    June 27, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT: UNKNOWN. DATE OF EVENT IS UNKNOWN. (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THERAPY DATE OF CONCOMITANT DEVICE IS UNKNOWN. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 28-JUN-2016. EXPIRATION DATE: 31-MAY-2026. PART #: 04.037.057S, LOT#: H133019 (STERILE) - 10 MM/130 DEG TI CANN TFNA 360 MM / LEFT - STERILE. QUANTITY 5. INSPECTION SHEET FOR TFNA ASSEMBLY INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: PART 04.037.942.2 - LOCK PRONG, 130 DEGREE, TFNA BP-55 LOT - 9959951. PART 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT - 9850952 . PART 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT - H117075 . PART 21127 - RAW MATERIAL LOT BP-80 LOT - H051521. RAW MATERIAL RECEIVED FROM SUPPLIER (B)(4). CERTIFICATE OF TEST RECEIVED FROM (B)(4) FOR TITANIUM INGOT MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET SPECIFICATION. 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. ¿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.

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE TFNA SCREW (PART 04.038.105 , LOT 7976790) WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION. UPON VISUAL INSPECTION THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION. THE NAIL (PART 04.037.057S, LOT H133019) WAS RETURNED IN TWO PIECES. THE NAIL BROKE IN TWO PIECES AT THE HELICAL BLADE INSERTION HOLE. IT IS AN OBLIQUE FRACTURE AND THE PROXIMAL FRAGMENT OF THE NAIL (WITH LOCKING MECHANISM) MEASURES APPROXIMATELY 53.14 MM. THE BALANCE OF THE IMPLANT SHOWS SIGNS OF BEING IMPLANTED/REMOVED. ALL MEASUREMENTS WERE TAKEN WITH CALIPER. THIS COMPLAINT IS CONFIRMED. A VISUAL INSPECTION, DEVICE HISTORY RECORD REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE 04.037.057S TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) IS AN IMPLANT INTENDED FOR TREATMENT OF FRACTURES OF THE FEMUR. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, THIS COMPLAINT CONDITION IS LIKELY CAUSED BY INSUFFICIENT REDUCTION OR DELAYED HEALING CAUSING INCREASED LOADS ON THE IMPLANT THAT WOULD NORMALLY BE SUPPORTED BY THE BONE, WHICH COULD EVENTUALLY CAUSE IT TO BREAK DUE TO MATERIAL FATIGUE. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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 TROCHANTERIC FIXATION NAIL ADVANCED (TFN) WAS IMPLANTED IN A PATIENT ON (B)(6) 2016. THE PATIENT IS REPORTED AS FEELING A POP IN HER FEMUR ON (B)(6) 2017 THEN LATER COMPLAINED OF HIP PAIN. THE PATIENT SCHEDULED A FOLLOW UP APPOINTMENT WHERE IT WAS DISCOVERED BY A CT SCAN THAT THE NAIL HAD BROKEN WHERE THE LAG SCREW GOES THROUGH. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 TO REMOVE THE NAIL AND LAG SCREW. THE PATIENT WAS REVISED TO AN OLDER TFN. THERE IS NO REPORT OF SURGICAL DELAY. SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: TFNA SCREW 105 MM (PART # 04.038.105S, LOT# 7976790, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522252 10MM/130 DEG TI CANN TFNA 360MM/LEFT ¿ STERILE ROX, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT H133019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PART # 04.038.105S, LOT# 7976790, QTY 1