BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILE

    MDR report key: 5694924 · Received June 2, 2016

    Report

    Report Number
    1719045-2016-10451
    Event Type
    Injury
    Date Received
    June 2, 2016
    Report Date
    May 17, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EXACT PATIENT WEIGHT (B)(6). DATE OF EVENT: UNKNOWN. (B)(4). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: NOVEMBER 05, 2015. EXPIRATION DATE: SEPTEMBER 30, 2025. PART 04.037.263S, LO 9934760 (STERILE): NO NON-CONFORMANCE REPORTS 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. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    UPDATED UNKNOWN CONCOMITANT SCREWS TO KNOWN CONCOMITANT SCREWS A PRODUCT INVESTIGATION WAS COMPLETED: THREE DEVICES WERE RECEIVED FOR INVESTIGATION. THE TFNA NAIL (PART 04.037.158, LOT 9944888) WAS BROKEN INTO TWO PIECES AT THE PROXIMAL LOCKING HOLE. IT DOES NOT APPEAR THAT ALL THE FRAGMENTS OF THE NAIL WERE RETURNED. PER THE COMPLAINT DESCRIPTION, THE PATIENT HAD DELAYED HEALING. THIS MEANS THAT THE NAIL WAS LIKELY THE PRIMARY LOAD BEARING DEVICE. UNDER THESE CONDITIONS IT IS LIKELY THAT THE NAIL BROKE DUE TO FATIGUE FROM CYCLIC LOADING, BUT THE EXACT CAUSE COULD NOT BE DETERMINED. THE LOCKING MECHANISM OF THE NAIL IS ALSO SEVERELY BENT AND MANGLED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. THE TWO CONCOMITANT 5.0MM TI LOCKING SCREWS (PART 04.005.530 AND 04.005.532, LOTS UNKNOWN) WERE ALSO RETURNED WITH NO COMPLAINT AGAINST THEM. NO ISSUES WERE FOUND WITH THESE DEVICES AND NO FURTHER INVESTIGATION IS REQUIRED. THE RELEVANT DRAWING FOR THE DEVICE(S) WAS REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. A 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. NO MANUFACTURING OR DESIGN ISSUES WERE NOTED DURING THE INVESTIGATION. THE DESIGN IS DETERMINED TO BE ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. 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 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 IMPLANT OF A TROCHANTERIC FIXATION NAIL DUE TO A GRADE I OPEN SUBTROCHANTERIC FRACTURE ON (B)(6) 2016, EXACT DATE IS UNKNOWN. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016 SECONDARY TO A BREAK IN THE NAIL AT THE JUNCTION WHERE THE NAIL MEETS THE HELICAL BLADE. IT WAS ALSO DISCOVERED THAT THE PATIENT HAD DELAYED HEALING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, NO FURTHER PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE. CONCOMITANT DEVICE REPORTED: HELICAL BLADE- PART AND LOT NUMBER ARE UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    CONCOMITANT DEVICE REPORTED: TWO 5.0MM TI LOCKING SCREWS (PART 04.005.530 AND 04.005.532, LOTS UNKNOWN)

    Description of Event or Problem · 1

    CONCOMITANT DEVICES: DISTAL LOCKING SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349383 12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 9934760

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention