BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.7MM & SMALL SCREWS

    MDR report key: 11118986 · Received January 5, 2021

    Report

    Report Number
    2939274-2021-00028
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Report Date
    December 8, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982189950
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS JNJ REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE HISTORY LOT: PART: 319.010, LOT: 9872604, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: AUG.09, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 2.7MM & SMALL SCREWS HOOK TIP WAS BENT. THE DEPTH GAUGE WAS USED TO MEASURE AND WAS BENT IMMENSELY. ANOTHER SET WAS OPENED TO BE ABLE TO MEASURE THE SCREWS. THE SURGERY WAS COMPLETED WITH AN UNKNOWN NUMBER OF SURGICAL DELAYS. THE PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14758 DEPTH GAUGE FOR 2.7MM & SMALL SCREWS GAUGE,DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 319.01 9872604 10886982189950

    Patients

    Seq Age Sex Outcome Treatment
    1