BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE

    MDR report key: 10515676 · Received September 10, 2020

    Report

    Report Number
    2939274-2020-04079
    Event Type
    Injury
    Date Received
    September 10, 2020
    Report Date
    August 13, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982096685
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JULY 30, 2018. EXPIRATION DATE: JUNE 30, 2028. PART: 04.037.160S, 11MM/130 DEG TI CANN TFNA 400MM / RIGHT ¿ STERILE. LOT: H693627 (STERILE). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN PROCESS / INSPECT DIMENSIONAL / FINAL MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, TFNA ASSEMBLY INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) WAS REVIEWED AND DETERMINED TO BE CONFORMING. STERILIZATION CONTROL NUMBER (SCN) SUPPLIED BY EES (ALBUQUERQUE) WAS REVIEWED AND DETERMINED TO BE CONFORMING. 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 PART(S) REVIEWED: PART: 04.037.942.2, LOCK PRONG, 130 DEGREE, TFNA BP55. LOT: L894359. PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART: 04.037.912.4, WAVE SPRING, SHIM ENDED BP55. LOT: H529599. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. MATERIAL CERTIFICATION AND CERTIFICATE OF CONFORMANCE AND QUALITY HISTORY CARD SUPPLIED BY SMALLEY WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART: 04.037.912.3, TFNA LOCK DRIVE BP58. LOT: H673200. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET MET ALL INSPECTION ACCEPTANCE CRITERIA. PART: 21127, TIMOAGRI16.00 BP80. LOT: H661491. CERTIFICATE OF ANALYSIS SUPPLIED BY METALWERKS WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING / PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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

    THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5095765. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980838 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.037.160S 10886982096685

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention