BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATCHETING ADAPTER, CANNULATED

    MDR report key: 11785652 · Received May 6, 2021

    Report

    Report Number
    1526439-2021-00915
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Report Date
    April 10, 2021
    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 · 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: INVESTIGATION SUMMARY: VISUAL INSPECTION: THE RATCHETING ADAPTER, CANNULATED (P/N: 286710490, LOT NUMBER: KM844159) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE DEVICE HAD FALLEN APART AND COULD NOT BE PUT BACK TOGETHER. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS PERFORMED ON THE COMPLAINT DEVICE. THE DEVICE WAS UNABLE TO BE ASSEMBLED BACK TOGETHER WITHOUT FALLING APART AGAIN. THE COMPLAINT WAS ABLE TO BE REPLICATED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE DEVICE HAD FALLEN APART AND COULD NOT BE PUT BACK TOGETHER. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 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. CORRECTED DATA: D9, H3, H6.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A SYNTHES EMPLOYEE. A REVIEW OF THE RECEIVING INSPECTION (RI) FOR RATCHETING ADAPTER, CANNULATED WAS CONDUCTED IDENTIFYING THAT LOT NUMBER KM844159 WAS RELEASED IN A SINGLE BATCH. BATCH1: RELEASED ON APRIL 20, 2017 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. PHOTO INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED. A PHOTO-INVESTIGATION WAS PERFORMED ON THE RECEIVED IMAGES. THE DEVICE WAS OBSERVED TO BE ¿FELL APART.¿ THE ETCHING ON THE DEVICE WAS FADED BUT HAS NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE NOTED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION, AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED DURING PHOTO INVESTIGATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO MANUFACTURING ISSUES WERE NOTED DURING INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE ADAPTER CAME DISASSEMBLED IN TWO PARTS. WHEN THE EQUIPMENT CONTAINER WAS OPENED, THE DEVICE HAD BEEN MARKED WITH RED TAPE AND LEFT INSIDE THE CONTAINER FOR REVIEW. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A RATCHETING ADAPTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678372 RATCHETING ADAPTER, CANNULATED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SPINE INC 286710490 KM844159 10705034213880

    Patients

    Seq Age Sex Outcome Treatment
    1