BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 12180990 · Received July 16, 2021

    Report

    Report Number
    2939274-2021-04134
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    January 1, 2021
    Report Date
    June 18, 2021
    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
    US
    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. PART: 319.006. SYNTHES LOT: H873105. SUPPLIER LOT: N/A. RELEASE TO WAREHOUSE DATE: (B)(6) 2020. EXPIRATION DATE: N/A. SUPPLIER: AVALIGN TECHNOLOGIES-NEMCOMED. NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. VISUAL INSPECTION: THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE NEEDLE COMPONENT WAS BROKEN AND WAS NOT RETURNED. THE DEVICE WAS ALSO MISSING THE PROTECTION SLEEVE COMPONENT. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE AND A DEFINITIVE FINDING OF A MISSING COMPONENT. DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DRAWING(S) WERE REVIEWED: DEPTH GAUGE FOR 2.0/ 2.4MM SCREWS (CURRENT)/ (MANUFACTURED) NEEDLE NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION THE COMPLAINT WAS CONFIRMED AS THE NEEDLE COMPONENT WAS BROKEN AND THE DEVICE WAS MISSING THE PROTECTION SLEEVE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, IT IS POSSIBLE THE DEVICE ENCOUNTERED UNINTENDED FORCES DURING USE AND THE MISSING COMPONENT OF THE DEVICE MIGHT BE MISPLACED WHEN TAKEN APART FOR STERILIZATION. 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 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

    PRODUCT COMPLAINT # (B)(4). EVENT YEAR IS REPORTED AS 2021; HOWEVER EXACT DATE OF EVENT IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; 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 THAT ON AN UNKNOWN DATE, DISCOVERED BEFORE A CASE, THE DEPTH GAUGES WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS. THIS REPORT IS 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081036 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE,DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 319.006 H873105 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| DEPTH GAUGE FOR 2.7MM & SMALL SCREWS| DEPTH GAUGE FOR 2.7MM & SMALL SCREWS| DEPTH GAUGE FOR 2.7MM & SMALL SCREWS