BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE

    MDR report key: 6223376 · Received January 4, 2017

    Report

    Report Number
    1719045-2017-10004
    Event Type
    Injury
    Date Received
    January 4, 2017
    Report Date
    December 12, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DURING THE SCHEDULED EXTENSION SURGERY THE DISLOCATED CRANIAL CRADLE (LEFT HYBRID TYPE) WAS ADDRESSED WHICH REQUIRED ADDITIONAL SURGICAL INTERVENTION. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT: DHR REVIEW FOR: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 23-APR-2015, EXPIRATION DATE: 31-MAR-2025, PART #: 04.037.156S, LOT#: 7990580 (STERILE) - 11MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE, QUANTITY 6. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO OTHER ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SCN NO: (B)(4) ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING." 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 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

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED ON THE RETURNED DEVICE (11MM/130 DEG TI CANN TFNA 360MM/RIGHT ¿ STERILE, PART # 04.037.156S, LOT # 7990580). THE RETURNED 130 DEGREE TFNA NAIL (PART 04.037.156, LOT 7990580) AND CONCOMITANT 80MM SCREW (PART 04.038.080, LOT 7948337) WAS EXAMINED. THE NAIL ARRIVED COMPLETELY FRACTURED AT THE JUNCTION BETWEEN THE NAIL AND THE PROXIMAL ELEMENT. THE SURFACE OF THE PROXIMAL END OF THE NAIL SHOWED SIGNIFICANT SURFACE WEAR THAT IS CONSISTENT WITH THE FAILURE MODE AS WELL AS INSERTION AND EXTRACTION OF THE IMPLANT. WHETHER THIS COMPLAINT CAN BE REPLICATED IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKEN. MEANINGFUL/ACCURATE MEASUREMENTS OF FEATURES RELEVANT TO THIS COMPLAINT (WALL THICKNESS AT LOCATION OF BREAKAGE) WERE UNABLE TO BE TAKEN AT CUSTOMER QUALITY (CQ) DUE TO DAMAGE (JAGGED EDGES AND ROLLED MATERIAL EDGES). UPON VISUAL INSPECTION OF THE SCREW, THERE IS NO EVIDENCE THAT THE DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION. THE OVERALL BALANCE OF THE DEVICE WAS IN GOOD CONDITION AND THE WEAR ALONG THE FLATS ARE CONSISTENT WITH INSERTION, USE, AND EXTRACTION. THEREFORE, NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS CONFIRMED. THE COMPLAINT DEVICES ARE PART OF THE DEPUY SYNTHES TFNADVANCED PROXIMAL FEMORAL NAILING SYSTEM FOR INTRAMEDULLARY FIXATION OF PROXIMAL FEMORAL FRACTURES PER TECHNIQUE GUIDE. RELEVANT DRAWINGS FOR THE RETURNED IMPLANT WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES AT THE TIME OF THE EVENT ARE UNKNOWN. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES REPORTED: TFNA SCREW (PART# 04.038.080S, LOT# 7948377, QUANTITY 1, LOT # SHOULD BE 7943377) REPLACE (B)(4) RATIONALE WITH: IT WAS REPORTED THAT THE PATIENT HAD A NON-UNION, THE NAIL BROKE POSTOPERATIVELY, AND THE EVENT REQUIRED ADDITIONAL SURGICAL INTERVENTION TO REMOVE THE CONSTRUCT AND CONVERSION TO A COMPETITOR PRODUCT. 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 THE PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION PROCEDURE ON (B)(6) 2016 DUE TO A NON-UNION AND A BROKEN DEVICE. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE SYNTHES DEVICES ON AN UNKNOWN DATE. THE HARDWARE REMOVED INCLUDED: ONE BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) AND ONE INTACT TFNA SCREW. THE DEVICES WERE SUCCESSFULLY REMOVED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR¿S DEVICE. THERE WAS NO REPORTED SURGICAL DELAY. THIS COMPLAINT INVOLVES ONE DEVICE. CONCOMITANT MEDICAL PRODUCTS: TFNA SCREW (PART# 04.038.080S, LOT# 7948377, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4495 11MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 7990580

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention