BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS

    MDR report key: 10528601 · Received September 14, 2020

    Report

    Report Number
    2939274-2020-04110
    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
    10886982189936
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: UPDATED DATA: H3, H6. INVESTIGATION SUMMARY. VISUAL INVESTIGATION: THE DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS (PART #: 319.004 AND LOT #: 6900420) WAS RECEIVED FOR INVESTIGATION AT US CQ. UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE, IT SHOWS THE DEPTH GAUGE NEEDLE HAS BROKEN OFF THE MAIN BODY AND THE BROKEN NEEDLE WAS NOT RETURNED. NO OTHER ISSUES IDENTIFIED WITH THE RETURNED DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION WILL BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: (MANUFACTURED) AND (CURRENT) WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE NEEDLE WAS BROKEN. NO DEFINITIVE CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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 #: 319.004. SYNTHES LOT NUMBER: 6900420. MANUFACTURING SITE: SYNTHES JENNERSVILLE. RELEASE TO WAREHOUSE DATE: MARCH 21, 2012. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. DEVICE HISTORY REVIEW. 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. 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

    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 ONE (1) DEPTH GAUGE BROKE OFF RESULTING IN THE ITEM BEING USELESS FOR ITS INTENDED PURPOSE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995562 DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS GAUGE, DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 319.004 6900420 10886982189936

    Patients

    Seq Age Sex Outcome Treatment
    1