BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 6574890 · Received May 18, 2017

    Report

    Report Number
    1719045-2017-10480
    Event Type
    Injury
    Date Received
    May 18, 2017
    Report Date
    April 21, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UDI: (B)(4). A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (12MM/130 DEG TI CANN TFNA 170MM - STERILE, PART NUMBER 04.037.242S, LOT NUMBER H041935). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING: THE RETURNED DEVICE WAS EVALUATED AND THE COMPLAINT CONDITION OF BROKEN: INTRAOPERATIVELY AND WAS ABLE TO BE CONFIRMED. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW, RISK ASSESSMENT, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. UPON VISUAL INSPECTION OF THE HELICAL BLADE, THERE IS NO EVIDENCE THAT THE DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION. THE OVERALL CONDITION OF THE DEVICE GOOD, AND THE WEAR ALONG THE SHAFT IS CONSISTENT WITH INSERTION, USE, AND EXTRACTION. THEREFORE, NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. THE TFNA NAIL BODY WAS BROKEN AT THE PROXIMAL LOCKING HOLE; BOTH PIECES OF THE NAIL WERE RETURNED. THE SURFACES OF THE NAIL RUPTURE ARE JAGGED AND CONSISTENT WITH THE FAILURE MODE. MEANINGFUL/ACCURATE MEASUREMENTS OF FEATURES RELEVANT TO THIS COMPLAINT (WALL THICKNESS AT LOCATION OF BREAKAGE) WERE UNABLE TO BE TAKEN AT CQ DUE TO DAMAGE (JAGGED EDGES AND ROLLED MATERIAL EDGES). THE OVERALL CONDITION OF THE DEVICE IS GOOD, DESPITE THE COMPLAINT CONDITION, SHOWING MINIMAL SIGNS OF WEAR. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE WAS RECEIVED BROKEN. THE DRAWING FOR THE DEVICE WAS REVIEWED, AND NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS COMPLAINT IS CONFIRMED, AS THE NAIL WAS RECEIVED BROKEN. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AS THE CIRCUMSTANCES AT THE TIME OF THE EVENT ARE UNKNOWN, NAIL BREAKAGE IN THIS FASHION IS NORMALLY DUE TO MALUNION OR NON-UNION WHERE THE FATIGUE LIMIT OF THE IMPLANT CONSTRUCT WAS MET, WHERE THE IMPLANTS WERE LOAD BEARING AND NOT LOAD SHARING. NORMAL HEALING TYPICALLY IS EXPECTED TWO TO THREE MONTHS POST-SURGERY. IN RARE INSTANCES WHERE BONE HEALING IS DELAYED, PATIENT NON-COMPLIANCE, OBESITY, ETC, THERE IS A MINOR CHANCE THAT IMPLANT FAILURE MAY OCCUR. IN OTHER RARE CASES WHERE THE EDGE OF THE HOLE IS DAMAGED, THERE IS A POTENTIAL FOR EARLY FATIGUE FAILURE. IT IS NOT LIKELY THAT THE DESIGN OF THE INSTRUMENT CONTRIBUTED TO THIS COMPLAINT. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE AS THE CIRCUMSTANCES AT THE TIME OF THE EVENT ARE UNKNOWN. IT IS NOT LIKELY THAT THE DESIGN OF THE DEVICE CONTRIBUTED TO THIS COMPLAINT. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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

    IMPLANT DATE IS UNKNOWN. IT WAS IN (B)(6) OF 2016. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER H041935. MANUFACTURING LOCATION: (B)(4). DATE OF MANUFACTURE: 24-FEB-2016. EXPIRATION DATE: 31-JAN-2026. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OR STERILIZATION OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OR STERILIZATION OF THE SUBJECT DEVICE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A TROCHANTERIC FIXATION NAIL ADVANCE (TFNA)NAIL (12MM/130° TITANIUM CANNULATED 170MM - STERILE) BREAK EIGHT PLUS WEEKS POSTOPERATIVE. PATIENT WAS IMPLANT SOMETIME IN (B)(6) 2016. X-RAYS WERE TAKEN 8 PLUS WEEKS POSTOPERATIVE. ALL OTHER EXPLANTED HARDWARE WAS FULLY INTACT. IT WAS REPORTED THAT DURING A REVISION SURGERY OF TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) IMPLANTS THE SURGEON HAD DIFFICULTY EXTRACTING THE DISTAL PORTION OF THE BROKEN NAIL. THE SURGERY WAS DELAYED BY 120 MINUTES AND REQUIRED ADDITIONAL INTERVENTION. SURGEON WAS ABLE TO REMOVE THE DISTAL PORTION OF THE NAIL USING THE TFNA NAIL EXTRACTOR, EXTRACTOR HOOK AND THE T-HANDLE CHUCK. WHEN IMPLANTING THE NEW TFNA (14MM/130° TITANIUM CANNULATED 380MM/LEFT - STERILE) THE DRIVING CAP CROSS THREADED INTO THE HYBRID INSERTION HANDLE. CROSS THREADING OBSTRUCTED LATERAL VIEWS OF THE HIP AND DELAYED LOCKING OF THE HELICAL BLADE. THE CONNECTING SCREW WOULD NOT RETAIN ON THE BALL HEX SCREWDRIVER, FALLING ONTO THE FLOOR. THE T-HANDLE CHUCK BENT MAKING IT DIFFICULT TO ADVANCE AND RETRACT THE 2.5 REAMING ROD. THE SURGEON ALSO STATED THAT DURING THE REVISION A LOCKING SCREW DEPTH GAUGE GAVE FALSE MEASUREMENTS, REQUIRING A SCREW TO BE REMOVED AND REPLACED FOR A CORRECT LENGTH SCREW. THIS PART OF THE COMPLAINT IS CAPTURED IN (B)(4). CONCOMITANT MEDICAL PRODUCTS: HELICAL BLADE (PART # 04.038.310S, LOT # H086275, QUANTITY 1) LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356150 12MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT H041935

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention LOCKING SCREW PART # UNKNOWN, LOT # UNK, QTY 1