BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM/130 DEG TI CANN TFNA 70MM - STERILE

    MDR report key: 6637449 · Received June 13, 2017

    Report

    Report Number
    1719045-2017-10571
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Report Date
    May 17, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. OTHER UDI: (B)(4). ORIGINAL IMPLANT DATE IS UNKNOWN, 6 MONTHS WITHIN REVISION DATE OF (B)(6) 2017. DATE RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 16-NOV-2016, EXPIRATION DATE: 31-OCT-2026. PART #: 04.037.042S, LOT#: H234693 (STERILE) - 10MM/130 DEG TI CANN TFNA 170MM - STERILE. QUANTITY 6. COMPONENT PARTS REVIEWED: PART 04.037.942.2 - LOCK PRONG, 130 DEGREE, TFNA BP-55 LOT - L028037. PART 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT - 9937548. PART 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT - H187538 PART 21127 - RAW MATERIAL LOT BP-80 LOT - H100076. RAW MATERIAL RECEIVED FROM SUPPLIER (B)(4). CERTIFICATE OF TEST RECEIVED FROM (B)(4) MEET SPECIFICATION. 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.¿ SUBJECT DEVICE HAS BEEN RECEIVED AND A PRODUCT INVESTIGATION WAS COMPLETED. THE FOLLOWING COMPLAINT DEVICE(S) WAS RECEIVED BY CUSTOMER QUALITY (CQ): ONE 10MM/130 DEG TI CANN TFNA 170MM - STERILE (PART NUMBER: 04.037.042S, LOT NUMBER: H234693, MFG DATE: 16NOV2016). THE PART(S) WAS RECEIVED WITH THE FOLLOWING COMPLAINT DESCRIPTION: ¿A LEFT TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) HARDWARE REMOVAL AND CONVERSION TO A TOTAL HIP PROSTHESIS WAS PERFORMED ON (B)(6) 2017. THE DATE OF ORIGINAL PROCEDURE TO REPAIR A PROXIMAL FEMUR FRACTURE IS UNKNOWN; IT WAS WITHIN 6 MONTHS OF THE (B)(6) 2017 PROCEDURE. THE UNDERLYING REASON FOR THE REMOVAL AND CONVERSION IS THAT THE BONE CUT OUT. THE FIXATION WAS SUCCESSFUL, BUT FEMORAL HEAD COLLAPSED. THE TFNA IMPLANT DID NOT HOLD THE FEMORAL HEAD IN PLACE AS IT SHOULD HAVE. HARDWARE WAS STICKING OUT OF THE BONE. IT IS THOUGHT TO BE THE BONE IS TO BLAME ¿NOT THE HARDWARE. (POSSIBLY WRONG CONSTRUCT CHOSEN FOR PATIENT); ON (B)(6) 2017 IS WAS NOTED DURING INSPECTION BY THE ENGINEERS THAT IT WAS DISCOVERED THAT THE LOCKING MECHANISM BROKE FROM THE NAIL¿. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, DRAWING REVIEW, DEVICE HISTORY RECORD REVIEW, RISK ASSESSMENT REVIEW, AND COMPLAINT HISTORY REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. 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 LEFT TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) HARDWARE REMOVAL AND CONVERSION TO A TOTAL HIP PROSTHESIS WAS PERFORMED ON (B)(6) 2017. THE DATE OF ORIGINAL PROCEDURE TO REPAIR A PROXIMAL FEMUR FRACTURE IS UNKNOWN; IT WAS WITHIN 6 MONTHS OF THE (B)(6) 2017 PROCEDURE. THE UNDERLYING REASON FOR THE REMOVAL AND CONVERSION IS THAT THE BONE CUT OUT. THE FIXATION WAS SUCCESSFUL, BUT FEMORAL HEAD COLLAPSED. THE TFNA IMPLANT DID NOT HOLD THE FEMORAL HEAD IN PLACE AS IT SHOULD HAVE. HARDWARE WAS STICKING OUT OF THE BONE. IT IS THOUGHT TO BE THE BONE IS TO BLAME ¿NOT THE HARDWARE. (POSSIBLY WRONG CONSTRUCT CHOSEN FOR PATIENT). THE INTACT TFNA CONSTRUCT WAS REMOVED, AND THE PATIENT WAS CONVERTED TO A TOTAL HIP. THERE WERE NO REPORTED SURGICAL DELAYS, NO SIGNS OF INFECTION, NO ADDITIONAL MEDICAL INTERVENTION OR ADDITIONAL X-RAYS REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE PATIENT IN STABLE CONDITION. ON (B)(6) 2017 IS WAS NOTED DURING INSPECTION BY THE ENGINEERS THAT IT WAS DISCOVERED THAT THE LOCKING MECHANISM BROKE FROM THE NAIL. THIS COMPLAINT IS FOR ONE DEVICE THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417780 10MM/130 DEG TI CANN TFNA 70MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT H234693

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR