SYMMETRY® RETRACTOR, ANKENEY STERNAL, ADULT
Received Feb 26, 2026
Report 3002750084-2026-00018 · MDR key 24455147
Device
Generic name
Sternal Retractor
Manufacturer
Aspen Surgical Products, Inc.Model number
54-0192Lot number
II533
Product problems
- Mechanical Jam
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED FOR EVALUATION. THE FUNCTIONALITY OF THE DEVICE WAS TESTED AS IF IT WERE IN A CLINICAL SETTING AND THE DEVICE FUNCTIONED AS INTENDED. THE PROBLEM COULD NOT BE REPRODUCED, AND THE DEVICE WAS WORKING WELL. NO ROOT CAUSE COULD BE ESTABLISHED. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative
THE DEVICE IS IN PROCESS OF BEING RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. ONCE WE HAVE ADDITIONAL RELEVANT INFORMATION IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
COMPLAINANT ALLEGES "THIS RETRACTOR IS FAILING AND WILL NOT TURN WHEN PRESSURE IS APPLIED."