BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR SMALL SCREWS

    MDR report key: 8708199 · Received June 18, 2019

    Report

    Report Number
    2939274-2019-58723
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Report Date
    May 21, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982189998
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: ADDITIONAL DATA-CONCOMITANT MEDICAL PRODUCTS. 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 · 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 319.090.500, LOT: L854300, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 23. MAY 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE DEPTH GAUGE F/LONG-SCR Ø3.5 MEAS-RANGE (P/N 319.090) WAS RECEIVED WITH ALL COMPONENTS: THE SLIDER HOOK ASSY (LOT L854300), GUIDE SLEEVE (LOT L854293), AND KNURLED CAP. THE DISTAL NEEDLE TIP ON THE SLIDER HOOK ASSY WAS OBSERVED TO BE BENT. NO BREAKAGE, FRACTURE, OR OTHER VISUAL ISSUES WERE OBSERVED ON THE RETURNED COMPONENTS OF THE DEVICE. THERE WAS DEVICE FAILURE/DEFECT IDENTIFIED, BUT UNRELATED TO REPORTED COMPLAINT CONDITION: THE DEVICE FAILURE/DEFECT OF BENT NEEDLE WAS IDENTIFIED DURING INVESTIGATION AND IS UNRELATED TO THE REPORTED COMPLAINT CONDITION. DIMENSIONAL INSPECTION: FEATURE: NEEDLE SHAFT DIAMETER WAS MEASURED AND FOUND TO BE CONFORMING AS PER RELEVANT DRAWING. DOCUMENT/SPECIFICATION REVIEW: THE RELEVANT DRAWINGS, REFLECTING THE MANUFACTURED AND CURRENT REVISION, WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION IS NOT CONFIRMED FOR THE DEPTH GAUGE F/LONG-SCR Ø3.5 MEAS-RANGE (P/N 319.090) AS NO BREAKAGE OR FRACTURE WAS OBSERVED ON THE RETURNED COMPONENTS OF THE DEVICE. ADDITIONALLY, THERE IS NO ¿BLACK PLASTIC¿ ON THE 319.090 DEPTH GAUGE. THE DEPTH GAUGE COMPONENTS ARE MANUFACTURED WITH STAINLESS STEEL. A DEVICE DEFECT OF A BENT DISTAL NEEDLE TIP WAS, HOWEVER, OBSERVED ON THE RETURNED SLIDER HOOK ASSY (WITH LOT L854300). WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THE BENT NEEDLE, IT IS POSSIBLE THAT THE CONDITION WAS DUE TO UNINTENDED FORCES. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, THE DEPTH GAUGE WAS DEFECTIVE. THE BLACK PLASTIC OF THE DEPTH GAUGE CORE AND THE METAL HOOK JUNCTION WAS BROKEN APART. THE DEPTH GAUGE DESIGN HAS A WEAK POINT AT THIS JUNCTION. A BACK UP DEPTH GAUGE WAS USED TO PROCEED WITH THE SURGERY. THERE WAS NO SURGICAL DELAY REPORTED. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501502 DEPTH GAUGE FOR SMALL SCREWS GAUGE,DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 319.09 L854300 10886982189998

    Patients

    Seq Age Sex Outcome Treatment
    1