BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS

    MDR report key: 11139750 · Received January 8, 2021

    Report

    Report Number
    2939274-2021-00120
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    December 14, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982075420
    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. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PART: 03.130.250. LOT: 9744237. MANUFACTURING SITE: BALSTHAL. RELEASE TO WAREHOUSE DATE: JANUARY 4, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. CUSTOMER QUALITY INVESTIGATION: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR INVESTIGATION. THE FOLLOWING INVESTIGATION IS BASED ON THE IMAGES. THE IMAGES WERE REVIEWED, AND THE COMPLAINT CONDITION COULD BE CONFIRMED, AS IT WAS OBSERVED THAT THE NEEDLE COMPONENT OF THE DEPTH GAUGE WAS BENT AND THE PART # AND LOT # OF THE DEPTH GAUGE COULD BE CONFIRMED IN THE RECEIVED PICTURES. SINCE, THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION AND A FUNCTIONAL TEST WERE NOT ABLE TO BE PERFORMED. A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT AS THE CIRCUMSTANCES DURING THE TIME OF THE EVENT ARE UNKNOWN. NO NEW MALFUNCTIONS WERE OBSERVED DURING THIS INVESTIGATION (BASED ON THE IMAGES) 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

    ADDITIONAL DEVICE PRODUCT CODES: HXP. REPORTER IS A SYNTHES EMPLOYEE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEPTH GAUGE FOR 1.3MM AND 2.0MM SCREWS WAS FOUND BENT IN STERILE PROCESSING DEPARTMENT (SPD). THERE IS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38071 DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS GAUGE, DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.130.250 9744237 10886982075420

    Patients

    Seq Age Sex Outcome Treatment
    1