BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRCAST

    MDR report key: 24933739 · Received April 20, 2026

    Report

    Report Number
    9616086-2026-00013
    Event Type
    Injury
    Date Received
    April 20, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 20, 2026
    Manufacturer
    DJO LLC
    Product Code
    KNP
    PMA / PMN Number
    C041456
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT WAS TREATED NON-OPERATIVELY FOR AN ACHILLIES INJURY ON (B)(6) WITH AN AIRCAST AIRSELECT 01EF-L LOT#: 251022-BB ON THE WEEKEND WITH AMBULATION, THE TOP STRAP BROKE WHERE THERE IS A WELD & STITCHING. THE PATIENT'S LOWER LEG MOVED ANTERIORLY IN THE BOOT WITH A SUDDEN LOSS OF SUPPORT AND REINJURED THEIR ACHILLIES. I WAS TOLD THE PATIENT WOULD NOW HAVE TO BE TREATED OPERATIVELY. THE DEVICE HAS BEEN RETURNED, THE STRAP IS DETACHED FROM THE DEVICE THE COMPLAINT HAS BEEN CONFIRMED, THE ROOT CAUSE HAS NOT BEEN ESTABLISHED. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TOP STRAP BROKE WHERE THERE IS A WELD & STITCHING. THE PATIENT'S LOWER LEG MOVED ANTERIORLY IN THE BOOT WITH A SUDDEN LOSS OF SUPPORT AND REINJURED THEIR ACHILLIES. I WAS TOLD THE PATIENT WOULD NOW HAVE TO BE TREATED OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168316 AIRCAST AIRSELECT, STANDARD, LARGE KNP DJO LLC 251022-BB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention