BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM/130 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 5946460 · Received September 13, 2016

    Report

    Report Number
    1719045-2016-10681
    Event Type
    Malfunction
    Date Received
    September 13, 2016
    Date of Event
    August 21, 2016
    Report Date
    August 21, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PRODUCT INVESTIGATION WAS COMPLETED. ONE 10MM/130 DEG TI CANN TFNA 170MM ¿ STERILE, PART #: 04.037.042S, LOT #: H132450 WAS RETURNED TO MANUFACTURER FOR INVESTIGATION. THE COMPLAINT CONDITION WAS CONFIRMED. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE RETURNED IMPLANT IS PART OF THE DEPUY SYNTHES TFN-ADVANCED (TFNA) PROXIMAL FEMORAL NAILING SYSTEM. THE HELICAL BLADE IS USED TO PREVENT THE NAIL FROM ROTATING ONCE FINAL POSITION AND LOCKING HAS TAKEN PLACE AS PER TECHNIQUE GUIDE. UPON VISUAL INSPECTION IT CAN BE SEEN THAT THE LOCKING MECHANISM OF THE NAIL HAS BEEN ENGAGED PRIOR TO INSERTION PREVENTING THE HELICAL BLADE FROM BEING INSERTED ONTO THE NAIL. ADDITIONALLY THERE ARE WITNESS MARKS AROUND THE HELICAL BLADE HOLE INDICATING THE IMPLANT WAS TRYING TO BE IMPLANTED. THE COMPLAINT IS CONFIRMED. A REVIEW OF THE CURRENT DESIGN DRAWING AND AVAILABLE HISTORY FOR THE TOP LEVEL DRAWING FOR THE IMPLANT WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. A DEVICE HISTORY RECORDS REVIEW WAS DONE AND SHOWED NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES AT THE TIME OF THE COMPLAINT ARE UNKNOWN. DEVICE 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

    PATIENT WEIGHT IS NOT PROVIDED. (B)(4). DEVICE MALFUNCTION WAS NOTED DURING THE IMPLANT PROCEDURE. DEVICE WAS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DHR REVIEW: PART NUMBER: 04.037.042S. SYNTHES LOT NUMBER: H132450. REVIEW LOCATION: MONUMENT. MANUFACTURE DATES: 06/28/2016. PART EXPIRATION DATE: 05/31/2026. THE REVIEW OF THE MANUFACTURING DHR SHOWED THAT THERE WERE NO ISSUES OR NONCONFORMANCE DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MONUMENT STERILITY ASSURANCE WAS CONTACTED AND THEY REVIEWED THE STERILE CONTROL NUMBER (SCN) RECORDS OF THE REPORTED LOT/PART NUMBER AND CONFIRMED THAT IT IS CONFORMING. THIS CONFIRMS THAT THE STERILITY ASSURANCE DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. DEVICE 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 ON (B)(6) 2016, PATIENT UNDERWENT SURGERY ON A LEFT HIP FRACTURE. DURING THE SURGERY, IT WAS NOTED THAT THERE WAS A MALFUNCTION WITH THE IMPLANT. IT WAS BELIEVED THAT THE LOCKING MECHANISM IN THE TFN-ADVANCED SHORT NAIL WAS ALREADY DOWN AND RECEIVED IN THAT CONDITION FOLLOWING SHIPMENT; THIS WAS NOT NOTED PRIOR TO ATTEMPTED IMPLANTATION. WHEN THE HELICAL BLADE WAS INSERTED, IT GOT JAMMED IN THE NAIL. BOTH THE BLADE AND NAIL WERE REMOVED AND OTHER PARTS WERE IMPLANTED. THERE WAS A 20-MINUTE DELAY IN SURGERY WITH NO REPORTED PATIENT HARM. THIS REPORT IS FOR ONE (1) TFN-ADVANCED SHORT NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599789 10MM/130 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT H132450

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR