BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5289926 · Received December 11, 2015

    Report

    Report Number
    1719045-2015-10819
    Event Type
    Injury
    Date Received
    December 11, 2015
    Date of Event
    November 23, 2015
    Report Date
    November 23, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED IMPLANT HAS SEVERE DAMAGE AND SIGNIFICANT LOSS OF MATERIAL ANTERIOR TO THE OBLIQUE HOLE. THE DAMAGE IS PARALLEL WITH THE OBLIQUE HOLE AXIS AND CONSISTENT WITH THE COMPLAINT DESCRIPTION. ONLY THE NAIL WAS RETURNED. THE OTHER INSTRUMENTS ASSOCIATED WITH THE COMPLAINT WERE UNAVAILABLE, HENCE, THE COMPLAINT EVENT CANNOT BE REPLICATED. WHEN THE NAIL WAS ASSEMBLED WITH INSTRUMENTS AVAILABLE, THE EVENT ALSO COULD NOT BE REPLICATED. THEREFORE THE COMPLAINT EVENT COULD BE CAUSED BY ANY OF THE INSTRUMENTS ASSOCIATED TARGETING OF THE HEAD ELEMENT THROUGH THE OBLIQUE HOLE OF THE NAIL. THE ROOT CAUSE OF THE COMPLAINT CONDITION IS UNKNOWN. NO MANUFACTURING OR DESIGN ISSUES WERE NOTED DURING THE INVESTIGATION. THE DESIGN 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

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. (B)(4). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DHR REVIEW WAS PERFORMED FOR: PART NUMBER: 04.037.159S. SYNTHES LOT NUMBER: 9904138. REVIEW LOCATION: MONUMENT. MANUFACTURE DATES: 10/21/2015. PART EXPIRATION DATE: 08/31/2025. THE REVIEW OF THE DHR SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMANCES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS 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 DRILL BIT MISSED THE NAIL AND WENT ANTERIOR TO THE NAIL DURING A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) PROCEDURE ON (B)(4). 2015. THE HELICAL BLADE WAS THEN INSERTED THRU THE DRILLED PATH AND RADIOGRAPHS WERE THEN TAKEN WHICH REVEALED THAT THE HELICAL BLADE WAS IMPLANTED ANTERIOR TO THE NAIL. THE HELICAL BLADE AND NAIL WERE THEN REMOVED AND THE SAME INSTRUMENTATION WAS UTILIZED AND A NEW NAIL AND HELICAL BLADE WERE INSERTED WITHOUT DIFFICULTY. IT WAS NOTED THAT AT THE START OF THE PROCEDURE THE ALIGNMENT OF THE INSTRUMENTATION WAS CHECKED AND CONFIRMED TO BE ACCURATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 30 MINUTE SURGICAL DELAY. THIS IS REPORT 5 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820758 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 9904138

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention