BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS

    MDR report key: 10528560 · Received September 14, 2020

    Report

    Report Number
    2939274-2020-04109
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Report Date
    August 17, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982075420
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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. VISUAL INSPECTION: THE PARE TIP F/DEPTH GAUGE NO. 03.130.250 (PART #: 03.130.250, LOT #: 3L99070) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION OF THE RECEIVED DEVICE, IT INDICATED THAT THE NEEDLE COMPONENT WAS BENT. NO OTHER DEVICE ISSUES WERE IDENTIFIED. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING CURRENT AND MANUFACTURING DRAWINGS WERE REVIEWED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT WAS CONFIRMED AS THE DEVICE NEEDLE COMPONENT WAS BENT. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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: 03.130.250, LOT: 3L99070, MANUFACTURING SITE: BALSTHAL, RELEASE TO WAREHOUSE DATE: APRIL 12, 2019. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    ADDITIONAL DEVICE PRODUCT CODES: HXP. THE DEVICE HAS BEEN 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 ON (B)(6) 2020, DURING A ROUTINE IN-SERVICE/SALES CALL WITH A SURGEON IT WAS DETERMINED THAT ONE (1) DEPTH GAUGE WAS BENT AND MEASUREMENTS WERE OFF WHILE THE TIP OF ANOTHER 1 DEPTH GAUGE BROKE OFF RESULTING IN THE ITEM BEING USELESS FOR ITS INTENDED PURPOSE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES 1 DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993581 DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS GAUGE, DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.130.250 3L99070 10886982075420

    Patients

    Seq Age Sex Outcome Treatment
    1