BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 95MM STERILE

    MDR report key: 6341295 · Received February 17, 2017

    Report

    Report Number
    3003506883-2017-10020
    Event Type
    Injury
    Date Received
    February 17, 2017
    Report Date
    January 24, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE HISTORY REVIEW: PART MFG DATE: 12 JUNE 2015. PART EXP. DATE: 31 MAY 2025. STERILITY REVIEW SITE: (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA HELICAL BLADE 95MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DEVICE HISTORY REVIEW: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 12-JUN-2015. EXPIRATION DATE: 31-MAY-2025. PART #: 04.038.295S, LOT#: 9801392 (STERILE) - TFNA HELICAL BLADE 95MM-STERILE, QUANTITY (B)(4). RAW MATERIAL LOT NO: (B)(4). NO NONCONFORMANCES 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 PATIENT ALSO HAD AN IRRIGATION AND DRAINAGE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH AN UNKNOWN INTRAMEDULLARY NAIL ON AN UNKNOWN DATE. ON (B)(6) 2017, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM AFTER SUFFERING A FALL. WHILE ADMITTED, X-RAYS WERE TAKEN THAT SHOWED THE INTRAMEDULLARY NAIL WAS BROKEN IN THE PROXIMAL FEMUR. ON (B)(6) 2017, AFTER DEVELOPING AN INFECTION, THE PATIENT WAS RETURNED TO THE OPERATING ROOM AND A TROCHANTERIC FIXATION NAIL ADVANCE (TFNA), A HELICAL BLADE, AND AN UNKNOWN 5.0 LOCKING SCREW WERE REMOVED. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122503 TFNA HELICAL BLADE 95MM STERILE ROD, FIXATION, INTRAMEDUILLARY HSB SYNTHES ELMIRA 9801392

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention