BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS

    MDR report key: 10347482 · Received July 30, 2020

    Report

    Report Number
    2939274-2020-03332
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 9, 2020
    Report Date
    July 9, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    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, H4, H6. INVESTIGATION SUMMARY: FLOW: DAMAGE. VISUAL INSPECTION: THE DEVICE) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION IT WAS NOTICED THAT THE NEEDLE COMPONENT WAS FOUND TO BE SEVERELY BENT DEFORMED AND THE PROTECTION SLEEVE COMPONENT IS MISSING. DIMENSIONAL INSPECTION: DRAWING: SPECIFIED DIMENSIONS: NEEDLE DIAMETER. MEASURED DIMENSIONS: NEEDLE DIAMETER = CONFORMING. DEVICE USED ¿ CA802. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? NO SINCE THE DEVICE WAS NOT FOUND BROKEN. INVESTIGATION CONCLUSION: THE POTENTIAL CAUSE FOR THE BENT NEEDLE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. 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 # 6945345. SUPPLIER LOT # NA. RELEASE TO WAREHOUSE DATE: MAY 18, 2012. MANUFACTURED BY SYNTHES JENNERSVILLE. NO NCR'S WERE GENERATED DURING PRODUCTION. 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, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF ANKLE. DURING THE PROCEDURE, THE TIPS OF THE TWO (2) DEPTH GAUGES BROKE OFF AND THE HOOKS OF THE OTHER TWO (2) DEPTH GAUGES WERE BENT. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP DEPTH GAUGES BUT WITH A TEN (10) MINUTE SURGICAL DELAY. THIS REPORT IS FOR 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
    807839 DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS GAUGE,DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 319.004 6945345 10886982189936

    Patients

    Seq Age Sex Outcome Treatment
    1