BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARM 1362275 UNIVERSAL FLEXIBLE

    MDR report key: 13737749 · Received March 11, 2022

    Report

    Report Number
    3014334038-2022-00050
    Event Type
    Malfunction
    Date Received
    March 11, 2022
    Date of Event
    February 17, 2022
    Report Date
    March 25, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    FXG
    UDI-DI
    10381780074670
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS:  D4, D9, G3, G6, H2, H3, H4, H10. THE UNIVERSAL FLEXIBLE ARM (1362275) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS & ROOT CAUSE - THE REPORTED COMPLAINT IS CONFIRMED. THE RETURNED 1362275 UNIVERSAL FLEXIBLE ARM IS IN USED CONDITION WITH THE TIP BROKEN OFF DUE TO INSUFFICIENT SOLDERING AND EXCESS TIGHTENING FORCE AT THE END OF THE ARM. SUPPLIER CORRECTIVE ACTION HAS BEEN INITIATED FOR THIS ISSUE, AND A RECALL WAS INITIATED FOR THIS PRODUCT ISSUE.

    Description of Event or Problem · 0

    THIS 3 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3014334038-2022-00049, 3014334038-2022-00048. A FACILITY REPORTED THAT THE UNIVERSAL FLEXIBLE ARM (1362275) BROKE IN THE MIDDLE OF A TYMPANOPLASTY PROCEDURE. ALL PARTS WERE RECOVERED AND WERE TAKEN OFF THE SURGICAL FIELD; NO FRAGMENTS FELL INTO THE SURGICAL SITE. IT WAS REPORTED THAT AN X-RAY WAS PERFORMED TO ASSURE THAT NO PARTS WERE LEFT IN THE PATIENT FOLLOWING THE EVENT. THE EVENT DID NOT LEAD TO PATIENT INJURY, DEATH, OR DELAY IN PROCEDURE.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225623 ARM 1362275 UNIVERSAL FLEXIBLE PFM11 FXG INTEGRA LIFESCIENCES MANSFIELD 1362275 10381780074670

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown