BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM/130 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 8422922 · Received March 14, 2019

    Report

    Report Number
    2939274-2019-56978
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Report Date
    January 22, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982095985
    PMA / PMN Number
    K160167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 CORRECTED DATA: D4: EXPIRATION DATE. 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

    OCCUPATION: REPORTER IS SYNTHES SALES CONSULTANT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 10/26/2018, EXPIRATION DATE: 09/30/2028, PART NUMBER: 04.037.042S, 10MM/130 DEG TI CANN TFNA 170MM ¿ STERILE, LOT NUMBER: H761290 (STERILE), LOT QUANTITY: (B)(4).,WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PARTS REVIEWED: COMPONENT PARTS WERE NOT REVIEWED. THE REPORTED COMPLAINT CONDITION OF ¿NAIL RETURNED TO CQ WITHOUT PACKAGING (POSSIBLY EXPLANTED)¿ DOES NOT INDICATE BREAKAGE OF THE NAIL OR ANY OF ITS COMPONENTS. THEREFORE, A DHR REVIEW OF THE COMPONENTS WOULD NOT BE PERTINENT TO THE COMPLAINT CONDITION. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AT CUSTOMER QUALITY (CQ) IDENTIFIED THAT THE INTERNAL LOCK PRONG COMPONENT IS MISSING AND THERE IS POST MANUFACTURING DAMAGE AROUND THE PROXIMAL HOLE WHICH SUGGESTS ATTEMPTED IMPLANTATION. THE SELECTED PEC IS "NON-PRODUCT ISSUE". THE RECEIVED CONDITION DOES NOT AGREE WITH THE COMPLAINT DESCRIPTION. COMPLAINT IS NOT CONFIRMED. DHR REVIEW: THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DOCUMENT/SPECIFICATION REVIEW: TOP LEVEL TABULATED ASSEMBLY DRAWING WAS REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION IS NOT APPLICABLE FOR THIS COMPLAINT. INVESTIGATION CONCLUSION: A DEFINITIVE ASSIGNABLE ROOT CAUSE FOR THE DEVICE'S CONDITION COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THIS COMPLAINT IS NOT CONFIRMED BECAUSE THE PEC IS "NON-PRODUCT ISSUE". NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL WAS RECEIVED WITHOUT ANY PACKAGING AND IT APPEARS TO BE AN EXPLANT. MINOR VISIBLE DAMAGE ON THE PROXIMAL LOCKING HOLE, LIKELY SUSTAINED DURING INSERTION. IT APPEARS THAT THE HOSPITAL SENT IT BACK DUE TO AN UNKNOWN REASON. A CURSORY INSPECTION OF THE DEVICE REVEALED NO ISSUES WITH IT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214763 10MM/130 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.037.042S H761290 10886982095985

    Patients

    Seq Age Sex Outcome Treatment
    1