BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TFNA 440MM/RIGHT - STERILE

    MDR report key: 6103674 · Received November 15, 2016

    Report

    Report Number
    1719045-2016-10830
    Event Type
    Injury
    Date Received
    November 15, 2016
    Report Date
    October 24, 2016
    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

    (B)(4). EXACT DATE OF ORIGINAL IMPLANT IS UNKNOWN. IMPLANT PROCEDURE WAS SEVEN (7) MONTHS PRIOR TO REVISION ON (B)(6) 2016. (B)(4). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 04.037.064S, LOT # 7984367. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: APR 24, 2015, EXPIRATION DATE: MAR 31, 2025. 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. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    DURING THE REVISION SURGERY THE BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) AND AN INTACT LAG SCREW WERE REMOVED. THE RETURNED NAIL IS BROKEN AT THE PROXIMAL LOCKING HOLE. THERE IS A HOLE WHICH WAS CREATED IN THE NAIL APPROXIMATELY 16MM DISTAL TO THE PROXIMAL LOCKING HOLE ALONG WITH HEAVY SCRATCHES AROUND THE AREA. THIS MOST LIKELY OCCURRED DURING THE REMOVAL OF THE BROKEN NAIL. THE THREADS FOR THE HEAD ELEMENT ARE DAMAGED. THE DEVICE SHOWS SOME OTHER MINOR SURFACE WEAR. THE RETURNED CONCOMITANT LAG SCREW SHOWS SIGNIFICANT SURFACE WEAR AND SOME DEFORMATION. THIS WAS LIKELY CAUSED BY THE BROKEN NAIL AS WELL AS THE EXPLANTATION PROCESS. 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. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, DHR REVIEW AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS CONFIRMED. DEVICE WAS USED FOR TREATMENT, NO 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 A REVISION PROCEDURE ON (B)(6) 2016 DUE TO A BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) AND A FRACTURE THAT HAD NOT HEALED COMPLETELY. THE ORIGINAL PROCEDURE TO REPAIR A RIGHT FEMUR FRACTURE WAS PERFORMED ON AN UNKNOWN DATE SEVEN (7) MONTHS PRIOR TO THE REVISION. THE BROKEN NAIL AND INCOMPLETE HEALING WAS DISCOVERED VIA COMPUTERIZED TOMOGRAPHY (CT) ON AN UNKNOWN DATE. DURING THE REVISION, THE BROKEN TFNA AND AN INTACT LAG SCREW WERE REMOVED. THE PATIENT WAS REVISED TO A TROCHANTERIC FIXATION NAIL (TFN) CONSTRUCT. THERE WAS A REPORTED SURGICAL DELAY OF LESS THAN TEN MINUTES RELATED TO THE REMOVAL OF THE DISTAL PORTION OF THE BROKEN NAIL. NO ADDITIONAL MEDICAL INTERVENTION OR ADDITIONAL X-RAYS WERE REQUIRED. NO FRAGMENTS WERE LEFT BEHIND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT MEDICAL PRODUCTS: 105MM TFNA LAG SCREW (PART #04.038.105S, LOT #9820725, QUANTITY 1). THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 440MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754791 10MM/130 DEG TI CANN TFNA 440MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 7984367

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PART #04.038.105S, LOT #9820725, QUANTITY 1