BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA FENESTRATED HELICAL BLADE 100MM - STERILE

    MDR report key: 10420092 · Received August 18, 2020

    Report

    Report Number
    2939274-2020-03590
    Event Type
    Injury
    Date Received
    August 18, 2020
    Report Date
    July 28, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982099297
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER: 04.038.400S, LOT NUMBER: H801142, PART MANUFACTURE DATE: 16-JAN-2019, MANUFACTURING LOCATION: (B)(4), PART EXPIRATION DATE: 31-DEC-2028, NONCONFORMANCE NOTED: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA FENESTRATED HELICAL BLADE 100MM ¿ STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH ONE REWORK AND NO NONCONFORMANCE'S. PER THE PRODUCT TRAVELER, 48 PARTS WERE REWORKED DUE TO UNEVEN SURFACE FINISH AND WERE CYCLED THROUGH TUB VIBRATORY. THIS REWORK WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE 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 NONCONFORMANCE 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. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE TFNA FENESTRATED HELICAL BLADE 100MM - STERILE (PART # 04.038.400S, LOT # H801142) WAS RECEIVED AT US CUSTOMER QUALITY (CQ), AND IT WAS NOTICED THAT THERE WAS A NICK ON THE OUTER SURFACE OF THE DEVICE. THE REST OF THE DEVICE SHOWS NO VISUAL DEFECTS. DOCUMENT/SPECIFICATION REVIEW: DRAWING(S) REVIEWED: (CURRENT & MANUFACTURED REVISIONS). DIMENSIONAL INSPECTION: THE OUTER DIAMETER OF THE PORTION ADJACENT TO HELIX SECTION WAS MEASURED. MEASURED: CONFIRMED. COMPLAINT CONFIRMED? NO. CONCLUSION: THE COMPLAINT CONDITION OF BENT WAS NOT CONFIRMED FOR THE RECEIVED TFNA FENESTRATED HELICAL BLADE 100MM - STERILE (PART # 04.038.400S, LOT # H801142). HOWEVER, IT WAS NOTICED THAT THE OUTER SURFACE OF THE DEVICE WAS NICKED. ALTHOUGH NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED, IT IS POSSIBLE THE BLADE EXPERIENCED UNINTENDED FORCES AFTER THE IMPLANTATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). 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 ON (B)(6) 2020, THE PATIENT UNDERWENT FEMUR REVISION DUE TO NON-UNION AND BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA) LONG NAIL. THE PATIENT'S STATUS WAS GOOD AND A NEW PROXIMAL FEMORAL NAILING SYSTEM (TFNA) WAS IMPLANTED. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE AND WERE EASILY REMOVED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 100MM - STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887874 TFNA FENESTRATED HELICAL BLADE 100MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.038.400S H801142 10886982099297

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention