BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE

    MDR report key: 6411568 · Received March 16, 2017

    Report

    Report Number
    1719045-2017-10228
    Event Type
    Injury
    Date Received
    March 16, 2017
    Report Date
    February 22, 2017
    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 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

    A PRODUCT INVESTIGATION WAS PERFORMED. THE FOLLOWING COMPLAINT DEVICE WAS RECEIVED BY CUSTOMER QUALITY (CQ): ONE 10MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE (PART NUMBER: 04.037.063S, LOT NUMBER: 9914672, MFG DATE: 07OCT2015). THE COMPLAINT CONDITION IS CONFIRMED. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. PLEASE NOTE A HELICAL BLADE (PART NUMBER: 04.038.300, LOT NUMBER: 7954175) WAS ALSO RETURNED, HOWEVER NO COMPLAINT ALLEGATIONS WERE MADE AGAINST THE IMPLANT AND THEREFORE NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. THE COMPLAINT DEVICES ARE PART OF THE DEPUY SYNTHES TFNADVANCED PROXIMAL FEMORAL NAILING SYSTEM FOR INTRAMEDULLARY FIXATION OF PROXIMAL FEMORAL FRACTURES (PER TECHNIQUE GUIDE). THE RETURNED TFNA NAIL 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 CQ DUE TO DAMAGE (JAGGED EDGES AND ROLLED MATERIAL EDGES). RELEVANT DRAWINGS FOR THE IMPLANT WERE REVIEWED. THE DRAWING WAS FOUND SUITABLE TO DETERMINE THE INTENDED DEVICE DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY. THE IMPLANT WAS FOUND TO HAVE MET THE DRAWING SPECIFICATIONS. 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. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. CONCOMITANT MEDICAL PRODUCTS: TFN-A HELICAL BLADE (PART # 04.038.300S, LOT # 7954175, QTY. 1), UNKNOWN 5MM LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QTY. 1). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 07-OCT-2015; EXPIRATION DATE: 31-AUG-2025; PART #: 04.037.063S, LOT#: 9914672 (STERILE) - 10MM/130 DEG TI CANN TFNA 420MM - STERILE. QUANTITY (B)(4). INSPECTION SHEET FOR IN PROCESS/INSPECT DIMENSIONAL/FINAL REV: D AND INSPECTION SHEET - TFNA ASSEMBLY INSPECTION REV:A MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: 04.037.942.2 - LOCK PRONG 130 DEGREE, TFNA BP-55 LOT - 9413482; 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT - 7840791; 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT - 9897577; 21127 - RAW MATERIAL LOT BP-80 LOT - 7432034. 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. (ETHICON), ¿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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED ON (B)(6) 2016 WITH A TFN-A (TROCHANTERIC FIXATION NAIL - ADVANCED) FOR A FRACTURED FEMUR. ON AN UNKNOWN DATE THE PATIENT RETURNED TO THE SURGEON COMPLAINING OF PAIN. X-RAYS TAKEN ON AN UNKNOWN DATE SHOWED A BROKEN NAIL. (X-RAYS NOT AVAILABLE) THE HELICAL BLADE AND ONE DISTAL SCREW WERE INTACT. THERE WAS NO EVIDENCE OF A NON-UNION. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2017. THE SURGEON DID SOME BURRING AND CURRETTING AROUND THE IMPLANTS, THEN REMOVED THE BLADE, DISTAL SCREW AND BOTH PIECES OF THE BROKEN NAIL. THE PATIENT WAS REVISED WITH ANOTHER TFN-A, AND AN ILIAC CREST AUTOGRAFT. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED SURGICAL DELAY, AND NO HARM TO THE PATIENT. THERE IS ONE DEVICE INVOLVED IN THIS COMPLAINT. CONCOMITANT MEDICAL PRODUCTS: TFN-A HELICAL BLADE (PART # 04.038.300S, LOT # 7954175, QTY. 1), UNKNOWN 5MM LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QTY. 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193764 10MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 9914672

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention