BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR

    MDR report key: 13416697 · Received February 1, 2022

    Report

    Report Number
    1526439-2022-00165
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 1, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HTD
    UDI-DI
    10705034214733
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTER IS A J&J EMPLOYEE. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE COMPLAINT DEVICE COMPRESSOR (PRODUCT CODE: 286740000, LOT NUMBER: KM810960) WAS RETURNED TO (B)(4) FOR INVESTIGATION. THE COMPRESSOR SPRING ASSEMBLY WAS BROKEN, PARTICULARLY ONE PORTION OF THE SPRING HAD BROKEN NEAR THE SCREW ATTACHING IT TO THE COMPRESSOR ARM. THE BROKEN PART WAS NOT RETURNED. DOCUMENT /SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWING WERE REVIEWED. DIMENSIONAL INSPECTION: COMPLAINT RELEVANT DIMENSION CANNOT BE MEASURED DUE TO DEVICE DESIGN. CONCLUSION: THE COMPRESSOR SPRING ASSEMBLY WAS BROKEN. A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED DURING INVESTIGATION. 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. A REVIEW OF THE RECEIVING INSPECTION (RI) FOR COMPRESSOR WAS CONDUCTED IDENTIFYING THAT LOT NUMBER KM810960 WAS RELEASED IN A SINGLE BATCH. (B)(4). 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 · 0

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE IS DAMAGED. NO ADDITIONAL INFORMATION AVAILABLE. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE COMPRESSOR SPRING ASSEMBLY WAS BROKEN. THIS DEVICE CONDITION WAS EVALUATED AND DETERMINED TO BE REPORTABLE ON JANUARY 31, 2022. THIS REPORT IS FOR ONE (1) VIPER SYSTEM COMPRESSOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496776 COMPRESSOR FORCEPS HTD MEDOS INTERNATIONAL SàRL CH 286740000 KM810960 10705034214733

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown