BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TFNA 380MM/LEFT ¿ STERILE

    MDR report key: 6515812 · Received April 24, 2017

    Report

    Report Number
    1719045-2017-10339
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Report Date
    March 29, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT. DATE OF DEVICE BREAKAGE IS NOT KNOWN. UDI: (B)(4). DEVICE WAS NOT IMPLANTED OR EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. PART #: 04.037.159S, LOT#: 7944151 (STERILE) - 11MM/130 DEG TI CANN TFNA 380MM / LEFT- STERILE. QUANTITY 6. COMPONENT PARTS REVIEWED: PART 04.037.942.2 - LOCK PRONG, 130 DEGREE, TFNA LOT - 9228833. PART 04.037.912.4 - WAVE SPRING, SHIM ENDED LOT - 7722155. PART 04.037.912.3 - TFNA LOCK DRIVE LOT - 7832230. PART 21127 - RAW MATERIAL LOT - 7912594. RAW MATERIAL RECEIVED FROM SUPPLIER PERRYMAN COMPANY. CERTIFICATE OF TEST RECEIVED FROM ALCOA MEET SPECIFICATION. INSPECTION SHEET FOR INPROCESS/INSPECT DIMENSIONAL/FINAL MET INSPECTION ACCEPTANCE CRITERIA. 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.¿ MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 20-MAR-2015. EXPIRATION DATE: 28-FEB-2025. 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 DEVELOPMENT INVESTIGATION WAS PERFORMED ON THE SUBJECT DEVICE. THE FOLLOWING COMPLAINT DEVICE(S) WAS RECEIVED BY CUSTOMER QUALITY (CQ): ONE 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE (PART NUMBER: 04.037.159S, LOT NUMBER: 7944151, MFG DATE: 20MAR2015). A VISUAL INSPECTION AND DEVICE HISTORY REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. APPROXIMATELY 44.76MM OF THE PROXIMAL END OF THE NAIL WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CLEARLY SHOWS THE NAIL HAS BROKEN AT THE LOCKING MECHANISM JUNCTION. 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). THE COMPLAINT DEVICES ARE PART OF THE DEPUY SYNTHES TFN ADVANCED PROXIMAL FEMORAL NAILING SYSTEM FOR INTRAMEDULLARY FIXATION OF PROXIMAL FEMORAL FRACTURES (PER TECHNIQUE GUIDE: (B)(4)). 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. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED AS THE CIRCUMSTANCES SURROUNDING THE COMPLAINT 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.

    Description of Event or Problem · 1

    IT IS REPORTED INSPECTION OF RETURNED EVALUATION EQUIPMENT REVEALED THE EDGE OF A STERILE TROCHANTERIC FEMORAL NAIL-ADVANCED (TFNA) IS DAMAGED AND SHOWS SOME CRACKING. IT WAS FURTHER NOTED THE DEVICE IS BROKEN. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297901 11MM/130 DEG TI CANN TFNA 380MM/LEFT ¿ STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 7944151

    Patients

    Seq Age Sex Outcome Treatment
    1