BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORIAN DRILLABLE INJECT 5CC-STERILE

    MDR report key: 11603493 · Received April 1, 2021

    Report

    Report Number
    2939274-2021-01641
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Report Date
    March 4, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    MQV
    UDI-DI
    10886982131614
    PMA / PMN Number
    K102722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D9. DATE DEVICE RETURNED TO MANUFACTURER. H6 - CODES UPDATED TO IMDRF CODES. VISUAL INSPECTION: THE NORIAN DRILLABLE INJECT 5CC-STERILE WAS RETURNED AND RECEIVED AT DSM BIOMEDICAL. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE MATERIAL IN THE POUCH HAD HARDENED INDICATING THAT SOME OF THE SOLUTION HAD BEEN SUCCESSFULLY INJECTED AND A REACTION HAD OCCURRED. THE CRACK ALONG THE LENGTH OF THE LUER LOCK WAS VISIBLE AFTER CLOSE INSPECTION. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: A FUNCTIONAL TEST WAS NOT PERFORMED AS IT WAS OBSERVED THAT THE LUER LOCK WAS CRACKED THUS CONFIRMING THE COMPLAINT CONDITION. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE? YES, VISUAL OBSERVATION OF THE DEVICE CONFIRMED THE LUER LOCK TO HAVE BEEN CRACKED LEADING TO THE NON-FUNCTIONALITY OF THE DEVICE. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE NORIAN DRILLABLE INJECT 5CC-STERILE AS THE LUER LOCK WAS CRACKED LEADING TO THE LEAKAGE OF THE CEMENT WHILE INJECTING. THE ROOT CAUSE FOR THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING RELATED ISSUE. NR-0173166 WAS INITIATED TO TRACK FURTHER INVESTIGATION OF THIS PRODUCT FAILURE. 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 HISTORY LOT - PART NUMBER:07.704.005S. SYNTHES LOT NUMBER: DS7006066. SUPPLIER LOT NUMBER: N/A. RELEASE TO WAREHOUSE DATE: 29DEC2020. EXPIRATION DATE: 28OCT2022. SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW: 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. 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

    REPORTER IS A J&J EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 ON UNKNOWN DATE, THE TWO EXTRA BOXES OF NORIAN DRILLABLE INJECT NEEDED TO BE OPENED BECAUSE THE NURSE FORGOT TO SQUEEGEE THE NORIAN INTO THE SYRINGE. TWO (2) NORIAN DRILLABLE INJECT CRACKED WHEN ATTACHING THE SYRINGE TO THE POUCH. IT WAS UNKNOWN WHEN THE ISSUE WHEN DISCOVERED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500874 NORIAN DRILLABLE INJECT 5CC-STERILE FILLER, CALCIUM SULFATE PREFORMED PELLETS MQV WRIGHTS LANE SYNTHES USA PRODUCTS LLC 07.704.005S DS7006066 10886982131614

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NORIAN DRILLABLE INJECT 10CC-STERILE| NORIAN DRILLABLE INJECT 3CC-STERILE