BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR TREPHINE ATTACHMENTS

    MDR report key: 11624338 · Received April 6, 2021

    Report

    Report Number
    2939274-2021-01718
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Report Date
    March 9, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWK
    UDI-DI
    10886982072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). REPORTER IS A J&J SALES REPRESENTATIVE. INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE SHAFT FOR TREPHINE ATTACHMENTS (PART # 03.111.030/ LOT # L967574) WAS RECEIVED AT US CQ. THE VISUAL INSPECTION OF THE RECEIVED DEVICE INDICATED THAT THE DISTAL PRONGS OF THE DEVICE WERE BROKEN OFF. NO FRAGMENTS WERE RETURNED. THE RECEIVED CONDITION WAS CONSISTENT WITH THE COMPLAINT CONDITION THUS THE COMPLAINT WAS CONFIRMED. DEVICE FAILURE/DEFECT IDENTIFIED? YES. THE DISTAL PRONGS BROKEN OFF. DIMENSIONAL ANALYSIS WAS NOT PERFORMED AS RELEVANT PARTS/FEATURES WERE NOT RETURNED AND DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: DRAWING(S) REVIEWED: (CURRENT & MANUFACTURED REVISION). CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED SHAFT FOR TREPHINE ATTACHMENTS AS THE PRONGS AT THE DISTAL END WERE BROKEN. ALTHOUGH NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED ITS POSSIBLE THE DEVICE ENCOUNTERED UNEXPECTED FORCES DURING USE. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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 HISTORY LOT, PART: 03.111.030, LOT: L967574. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: JULY 24, 2018. 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, ITEM WAS GIVEN BY STERILE PROCESSING DEPARTMENT STAFF WITH THE TABS BROKEN OFF TREPHINE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SHAFT FOR TREPHINE ATTACHMENTS. THIS REPORT IS 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522078 SHAFT FOR TREPHINE ATTACHMENTS TREPHINE HWK WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.111.030 L967574 10886982072283

    Patients

    Seq Age Sex Outcome Treatment
    1