BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR SMALL SCREWS

    MDR report key: 11648981 · Received April 12, 2021

    Report

    Report Number
    2939274-2021-01795
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Report Date
    March 15, 2021
    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
    NJ, 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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE DEPTH GAUGE FOR SMALL SCREWS (P/N: 319.09; LOT# 9140923 )WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE SLIDER ASSEMBLY COMPONENT WAS RECEIVED WITH A LOT NUMBER: 8985479 ETCHED ON IT, IT WAS ALSO OBSERVED THAT THE TIP OF THE MEASURING HOOK WAS BENT AND DEFORMED. THE DIFFERENCES IN THE LOT NUMBERS BETWEEN THE COMPONENTS INDICATES THE CUSTOMER HAD POTENTIALLY DISASSEMBLED THE DEVICES FOR CLEANING AND STERILIZATION AND MIXED UP THE COMPONENTS WITH OTHER DEVICE COMPONENTS WHEN REASSEMBLING THEM. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. SERVICE AND REPAIR EVALUATION: IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, A DEPTH GAUGE FOR SMALL SCREWS WAS BENT. THE REPAIR TECHNICIAN REPORTED THE DEVICE WAS BENT. BENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE THE RELEVANT DRAWINGS, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE DEPTH GAUGE FOR SMALL SCREWS AS THE MEASURING HOOK WAS BENT. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE ROOT CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. 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. H3, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 319.090, LOT: 9140923, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 01.OCTOBER 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. PART: 319.090.500, LOT: 8985479, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 30. JULY 2014. 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.

    Additional Manufacturer Narrative · 1

    REPORTER IS A J&J EMPLOYEE. THE SUBJECT DEVICE IS RECEIVED, THE INVESTIGATION IS IN PROGRESS, 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, DURING A ROUTINE INSPECTION OF A LOANER SET A DEPTH GAUGE FOR SMALL SCREWS WAS BENT. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544575 DEPTH GAUGE FOR SMALL SCREWS GAUGE, DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 319.09 9140923 10886982189998

    Patients

    Seq Age Sex Outcome Treatment
    1