BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE

    MDR report key: 6133005 · Received November 29, 2016

    Report

    Report Number
    1719045-2016-10863
    Event Type
    Injury
    Date Received
    November 29, 2016
    Report Date
    November 4, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID: (B)(6). (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: DECEMBER 15, 2015. EXPIRATION DATE: OCTOBER 31, 2025. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    ADDITIONAL NARRATIVE: PATIENT AGE PROVIDED FOR REPORTING. UPDATED EVENT DESCRIPTION. UPDATED CONCOMITANT DEVICES. 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

    ADDITIONAL PATIENT ID: (B)(6). 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 A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) BROKE POSTOPERATIVELY. THE PATIENT PRESENTED WITH PAIN DURING A FOLLOW UP VISIT ON AN UNKNOWN DATE, UNPLANNED X-RAYS CONFIRMED THE DEVICE BREAKAGE. A REVISION SURGERY OCCURRED (B)(6) 2016. ONE (1) BROKEN NAIL, ONE (1) INTACT HELICAL BLADE, AND TWO (2) INTACT LOCKING SCREWS WERE REMOVED. FRAGMENTS WERE GENERATED FROM THE NAIL BREAKAGE AND REMOVED; NO FRAGMENTS WERE LEFT BEHIND IN THE PATIENT. DURING THE REVISION SURGERY, NON-UNION WAS DETERMINED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO SURGICAL DELAY OR ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS REVISED TO A NEW NAIL. THE PATIENT STATUS IS UNKNOWN. THE ORIGINAL IMPLANT FOR THE NAIL WAS (B)(6) 2016. CONCOMITANT DEVICES: HELICAL BLADE (PART 04.038.305, LOT 7822874, QUANTITY 1); LOCKING SCREW (PART/LOT UNKNOWN, QUANTITY 2). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    (B)(4) 2017, COMPLAINT WAS RE-OPENED TO ADDRESS LEGAL NOTIFICATION AND SUBSEQUENT ADDITIONAL INFORMATION AND INVESTIGATION. PATIENT INFORMATION, EVENT DESCRIPTION AND CONCOMITANT DEVICES UPDATED. PLEASE NOTE: A SECOND COMPLAINT WILL BE OPENED TO INVESTIGATE PATIENT REPORTS OF PAIN DURING FOLLOW UP VISITS POST REVISION SURGERY. (B)(4) WAS OPENED TO CAPTURE PAIN AND SUPERFICIAL WOUND INFECTION. IT WAS REPORTED ON (B)(6) 2016 THAT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) BROKE POSTOPERATIVELY. THE PATIENT PRESENTED WITH PAIN DURING A FOLLOW UP VISIT ON AN UNKNOWN DATE, UNPLANNED X-RAYS CONFIRMED THE DEVICE BREAKAGE. A REVISION SURGERY OCCURRED (B)(6) 2016, WHERE ONE (1) BROKEN NAIL, ONE (1) INTACT HELICAL BLADE, AND TWO (2) INTACT LOCKING SCREWS WERE REMOVED. FRAGMENTS WERE GENERATED FROM THE NAIL BREAKAGE AND REMOVED. NO FRAGMENTS WERE LEFT BEHIND IN THE PATIENT. DURING THE REVISION SURGERY, NON-UNION WAS DETERMINED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO SURGICAL DELAY OR ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS REVISED TO A NEW NAIL. PATIENT STATUS IS UNKNOWN. THE INITIAL PROCEDURE WAS A LEFT HIP DISPLACED BASICERVICAL INTERTROCHANTERIC/SUBTROCHANTERIC FRACTURE ORIGINALLY IMPLANT FOR THE NAIL WAS TREATED ON (B)(6) 2016 BECAUSE THE PATIENT SUSTAINED A FALL. CONCOMITANT DEVICES: HELICAL BLADE (PART# 04.038.305S LOT# 9933381, QTY 1); LOCKING SCREW (PART# 04.005.546S, LOT# H037994, QTY 1); LOCKING SCREW (PART# 04.005.536S LOT# 9914446, QTY 1).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT: IT WAS REPORTED THAT AFTER REPEATED COMPLAINTS OF PATIENT PAIN ON (B)(4) 2016 AND (B)(6) 2016, PATIENT HAD POST-OPERATIVE VISIT ON (B)(6) 2016. DURING THIS VISIT, THE NAIL WAS DETERMINED TO BE BROKEN JUST ABOVE THE HELICAL BLADE BY AP, X-RAY AND LATERAL X-RAYS. SECONDARY X-RAYS WERE TAKEN ON (B)(6) 2016 AND IT WAS DETERMINED THAT THERE WAS MILD LATERAL DISPLACEMENT AND MEDIAL ANGULATION OF THE DISTAL FRACTURE FRAGMENT. THE BREAK IN THE NAIL WAS CLEARLY SEEN. THERE WAS DEVELOPMENT OF A TRANSVERSELY ORIENTED BONY FRACTURE BELOW THE LEVEL OF THE COMPRESSION SCREW AT THE LEVEL OF THE LESSER TROCHANTER. REVISION WAS SCHEDULED AND COMPLETED (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783882 10MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 9947789

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention 1 PART 04.038.305, LOT 7822874, HELICAL BLADE| 2 UNKNOWN LOCKING SCREWS