BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 7885223 · Received September 18, 2018

    Report

    Report Number
    2939274-2018-53815
    Event Type
    Malfunction
    Date Received
    September 18, 2018
    Report Date
    July 13, 2018
    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
    LA, 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. 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 · 0

    THIS IS REPORT 1 OF 2 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. IT IS UNKNOWN WHEN DEVICE BROKE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTER EMAIL ADDRESS IS UNAVAILABLE. REPORTER IS A SYNTHES SALES CONSULTANT. PART: 319.006; LOT: 9874105; RELEASE TO WAREHOUSE DATE: AUGUST 24, 2015; MANUFACTURED BY SYNTHES (B)(4). NO NONCONFORMANCE REPORTS (NCR'S) WERE GENERATED DURING PRODUCTION. THE RAW MATERIAL CERTIFICATES WERE CHECKED, AND THE USED RAW MATERIAL HAS FULFILLED THE SPECIFICATIONS. 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. CUSTOMER QUALITY INVESTIGATION: INVESTIGATION FLOW: BROKEN. VISUAL INSPECTION: VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY (CQ) ON THE RETURNED DEVICE CONFIRMED THE CONDITION OF BROKEN NEEDLE, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION. THE TIP/NEEDLE WAS OBSERVED BROKEN AT ITS CONNECTION TO ITS BODY OF THE DEPTH GAUGE. BROKEN NEEDLE WAS NOT RETURNED AT CUSTOMER QUALITY. NO NEW ISSUES WERE OBSERVED. DOCUMENT/SPECIFICATION REVIEW: DESIGN DRAWING FROM THE TIME OF MANUFACTURE TO CURRENT WAS REVIEWED DURING THIS INVESTIGATION AND NO ISSUES WERE IDENTIFIED. DEPTH GAUGE TOP LEVEL DRAWING; NEEDLE DRAWING. DIMENSIONAL INSPECTION ON RELEVANT PORTIONS WAS NOT ABLE TO BE PERFORMED AS THE DEVICE NEEDLE WAS NOT RETURNED. 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. FURTHERMORE, THE MATERIAL REVIEW PERFORMED SHOWN THAT USED RAW MATERIAL HAS FULFILLED THE SPECIFICATIONS. CONCLUSION: NO ROOT CAUSE COULD BE DETERMINED WITH THE AVAILABLE INFORMATION. HOWEVER, IT IS POSSIBLE THAT ANY UNINTENDED FORCES ENCOUNTERED BY THE DEVICE DURING USAGE WITH CONSISTENT USAGE FOR APPROXIMATELY 3 YEARS COULD HAVE CONTRIBUTED TO COMPLAINT CONDITION. THIS COMPLAINT IS CONFIRMED, HOWEVER NO UNIDENTIFIED PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. THEREFORE, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSPECTION OF A FIELD SALES SET MODULAR MINI FRAGMENT LOCKING COMPRESSION PLATE ON AN UNKNOWN DATE, A DEPTH GAUGE WAS BROKEN. THIS HAPPENED SOMETIME DURING WASHING THE SET BECAUSE THE DEPTH GAUGE WAS IN WORKING ORDER DURING USE OF THE SET DURING THE PRIOR PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725472 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9874105 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1