BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 12368479 · Received August 25, 2021

    Report

    Report Number
    2939274-2021-04925
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    July 28, 2021
    Report Date
    July 29, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982189943
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. H3, H4, H6: PART # 319.006, SYNTHES LOT # H873105, SUPPLIER LOT # H873105, RELEASE TO WAREHOUSE DATE: 15 SEP2020, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE COMPLAINT DEVICE DEPTH GAUGE FOR 2.0MM AND 2.4MM WAS RETURNED TO CUSTOMER QUALITY (CQ) WEST CHESTER FOR INVESTIGATION. THE NEEDLE OF THE DEPTH GAUGE HAD BROKEN OFF BUT IT WAS NOT RETURNED WITH THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED ON THE DEVICE. DEVICE/DEFECT IDENTIFIED: YES. DOCUMENT /SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED VERSION OF DRAWINGS FOR THE PART WERE REVIEWED: DEPTH GAUGE FOR 2.0/2.4MM SCREWS, (CURRENT AND MANUFACTURED) BODY (CURRENT AND MANUFACTURED). DIMENSIONAL INSPECTION: DIAMETER OF THE HOLE FOR NEEDLE (CONFORMING). COMPLAINT CONFIRMED: YES, THE COMPLAINT CONDITION OF BROKEN CAN BE CONFIRMED BASED ON THE AVAILABLE INFORMATION. CONCLUSION: THE NEEDLE OF THE DEPTH GAUGE HAD BROKEN OF THE GRADUATED BODY. THE POTENTIAL ROOT CAUSE OF THE ISSUE CANNOT BE IDENTIFIED. DURING INVESTIGATION NO MANUFACTURING OR DESIGN DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ASSIGNABLE ROOT CAUSE CANNOT BE DETERMINED FROM THE PROVIDED INFORMATION. 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. 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 SALES REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. 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 (B)(6) 2021, THE DEPTH GAUGE WAS BROKE IN SPD WHILE BEING CLEANED. THIS REPORT IS FOR 1 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265462 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 319.006 H873105 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1