BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA FEM NAIL Ø10 R 125° L320 TIMO15

    MDR report key: 7248135 · Received February 7, 2018

    Report

    Report Number
    8030965-2018-50915
    Event Type
    Injury
    Date Received
    February 7, 2018
    Report Date
    January 15, 2018
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819649767
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.037.022S, LOT# H035237. MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: FEB 19, 2016, EXPIRY DATE: FEB 28, 2026. 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. INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL AND INSPECTION SHEET - TFNA ASSEMBLY INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: 04.037.912.2 - LOCK PRONG 125 DEGREE, TFNA BP-55 LOT - 9668017, 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT - 7921060 , 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT - 9982091 . 21127 - RAW MATERIAL LOT BP-80 LOT ¿ 7926421. RAW MATERIAL FOR TITANIUM RECEIVED FROM METALWERKS PMD, INC. CERTIFICATE OF ANALYSIS RECEIVED FROM METALWERKS PMD, INC. AND RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET SPECIFICATION. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. AS PER THE TECHNIQUE GUIDE, THE RETURNED 10MM/125 DEGREE TI CANNULATED TFNA 320MM/LEFT (04.037.022S) IS A COMPONENT OF THE TITANIUM TFNA SYSTEM FOR INTRAMEDULLARY FIXATION OF PROXIMAL FEMUR FRACTURES. THE RETURNED DEVICE WAS EXAMINED AND THE COMPLAINT CONDITION COULD BE CONFIRMED AS THE DEVICE WAS FOUND TO BE BROKEN AT THE PROXIMAL LOCKING HOLE. BASED ON THE COMPLAINT DESCRIPTION THE DEVICE FAILED WHILE THE PATIENT WAS WEIGHT-BEARING DURING REHABILITATION. THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED DUE TO POST-MANUFACTURING DAMAGE. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THIS DEVICE. NO DIMENSIONAL ANALYSIS IS POSSIBLE DUE TO POST-MANUFACTURING DAMAGE. A DEVICE HISTORY REVIEW, INCLUDING MATERIAL AND HARDNESS REVIEWS, WAS PERFORMED FOR THE RETURNED IMPLANT¿S LOT NUMBER AND NO MATERIAL REVIEW REPORTS, NON- CONFORMANCE REPORTS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THESE DATES WERE INCORRECTLY REPORTED AS 1/16/2018 IN THE INITIAL REPORT. THE CORRECT DATE IS 1/15/2018. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT ID, DOB AND WEIGHT NOT PROVIDED FOR REPORTING. UNKNOWN WHEN THE BREAKAGE OCCURRED. (B)(6). ADDITIONAL 510K: K160167. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 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

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN ORIGINAL SURGERY ON (B)(6) 2017, THE REPORTED DEVICE WAS USED FOR THE FEMUR SUBTROCHANTERIC FRACTURE. AS A POSTOPERATIVE REHABILITATION, THE PATIENT STARTED WEIGHT BEARING. JUDGING FROM PATIENT¿S LESSENED PAIN, THE SURGEON THOUGHT THE FRACTURES HAD BEEN UNDER SMOOTH BONE HEALING. SINCE THEN, HOWEVER, POROSIS SEEMED TO HAVE BEEN SLOWER, AND FINALLY THE PATIENT FELT SUDDEN PAIN. X-RAYS SHOWED TFNA (TFN-ADVANCED PROXIMAL FEMORAL NAILING SYSTEM) FEMORAL NAIL IN QUESTION HAD BREAKAGE WHERE A BLADE WAS INSERTED. ON (B)(6) 2018, THE NAIL WAS REPLACED WITH A ONE-SIZE BIGGER NAIL, AND THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE: 1X UNK BLADE. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93575 TFNA FEM NAIL Ø10 R 125° L320 TIMO15 ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF : SYNTHES PRODUKTIONS GMBH H035237 07611819649767

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention