BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATCHETING ADAPTER, CANNULATED

    MDR report key: 11605542 · Received April 1, 2021

    Report

    Report Number
    1526439-2021-00613
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    August 11, 2020
    Report Date
    August 12, 2020
    Manufacturer
    DEPUY SPINE INC
    Product Code
    LXH
    UDI-DI
    10705034213880
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: REPORTER IS A J&J EMPLOYEE. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE RATCHETING ADAPTER, CANNULATED (P/N: 286710490, LOT #: KM863358) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, SCRATCHES WERE OBSERVED AND THE ETCH ON THE DEVICE STARTED TO FADE BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: DURING THE FUNCTIONAL TEST, THE FUNCTIONAL EVALUATION OF THE ADAPTOR CONFIRMS THAT THE RATCHETING MECHANISM IS FUNCTIONING AS INTENDED IN ALL DIRECTIONS. A FURTHER FUNCTIONAL TEST CANNOT BE PERFORMED AS THE DEVICE WAS RETURNED BY ITSELF. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE INTERNAL COMPONENTS WERE INACCESSIBLE WITHOUT THE DESTRUCTION OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE OF THE RELEVANT DRAWINGS, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS NOT CONFIRMED FOR THE RATCHETING ADAPTER (P/N: 2867-10-490, LOT #: KM873393). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: A REVIEW OF THE RECEIVING INSPECTION (RI) FOR RATCHETING ADAPTER, CANNULATED WAS CONDUCTED IDENTIFYING THAT LOT NUMBER KM863358 WAS RELEASED IN A SINGLE BATCH. BATCH1: LOT UNITS WERE RELEASED ON (B)(6) 2018 WITH NO DISCREPANCIES. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6), 2020, THE RATCHETING ADAPTER WAS BLOCKED AND DID NOT ALLOW FORWARD ADVANCEMENT OR RETRACTION OF THE ANKLE WHEN ASSEMBLED ON THE SCREWDRIVER SHAFT. SCREW PLACEMENT WAS PERFORMED WITHOUT USING THE RATCHETING ADAPTER. THERE WAS NO DELAY DUE THE REPORTED EVENT. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) RATCHETING ADAPTER, CANNULATED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502210 RATCHETING ADAPTER, CANNULATED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SPINE INC 286710490 KM863358 10705034213880

    Patients

    Seq Age Sex Outcome Treatment
    1