BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORIAN DRILLABLE INJECT 10CC-STERILE

    MDR report key: 7249692 · Received February 7, 2018

    Report

    Report Number
    2939274-2018-50541
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    January 16, 2018
    Report Date
    January 16, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    MQV
    UDI-DI
    10886982131621
    PMA / PMN Number
    K102722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW WAS COMPLETED. PART NUMBER: 07.704.010S , SYNTHES LOT NUMBER: DSD7643 , SUPPLIER LOT NUMBER: N/A , RELEASE TO WAREHOUSE DATE: 15-DEC-2016 , EXPIRATION DATE: 28-FEB-2018 , SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. THE ITEM WAS FORWARDED TO DSM AND THE CONCLUDED: COMPLAINT (B)(4) WAS REVIEWED AND CLOSED ON FEBRUARY 22, 2018. A REVIEW OF DHF NORIAN FIBER REINFORCED ROTARY POUCH, 80030-03, D7643, AND FILLED SYRINGES FOR NORIAN FIBER REINFORCED ROTARY POUCH, 6839-03, D0501 WAS COMPLETED AND THE PRODUCT MET ALL ACCEPTANCE CRITERIA FOR COMMERCIAL RELEASE. THE DHF REVIEW INCLUDED ALL INCOMING, IN-PROCESS, AND FINAL INSPECTIONS, SPECIFICATIONS, AND MANUFACTURING PROCESSES. NO DEVIATIONS OR NCR'S WERE ISSUED DURING THE MANUFACTURING OF THE PRODUCTS RELATED TO THIS COMPLAINT. ROOT CAUSE COULD NOT BE CONFIRMED. ALL APPLICABLE DEVICE HISTORY FILES AND RISK ASSESSMENTS WERE REVIEWED, AND NO DISCREPANCIES APPLICABLE TO THIS COMPLAINT WERE NOTED. IT HAS BEEN DETERMINED THAT THERE IS NO ASSIGNABLE CAUSE TO THE DEVICE, AS THE DEVICE HISTORY FILE REVIEW SHOWED NO DISCREPANCIES OCCURRED DURING THE MANUFACTURING OF THIS LOT; HOWEVER, THE LIKELY CAUSE FOR THIS COMPLAINT IS DETERMINED TO BE END USER ERROR. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. ADDITIONAL 510K: K073303. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    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 DURING A TARSOMETATARSAL (TMT) FOOT FUSION ON (B)(6) 2018, THE NURSE WAS ABOUT TO MIX THE NORIAN AND REMOVED THE CAP ON THE LIQUID PART OF THE SYRINGE WHEN THE LOCK CAME OFF AND PREVENTED THE LIQUID FROM MIXING INTO THE POWDER PACKET. ANOTHER NORIAN PACK WAS USED, BUT THE SURGEON HAD TO LOWER THE PATIENT¿S TOURNIQUET THEN RAISE IT BACK UP AND START OVER. THIS RESULTED IN A TEN (10) MINUTE SURGICAL DELAY. NO PATIENT HARM. PROCEDURE COMPLETE SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91811 NORIAN DRILLABLE INJECT 10CC-STERILE FILLER, CALCIUM SULFATE PREFORMED PELLETS MQV WRIGHTS LANE SYNTHES USA PRODUCTS LLC 07.704.010S DSD7643 10886982131621

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR