MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. SYMMETRY® RETRACTOR, ANKENEY STERNAL, ADULT; STERNAL RETRACTOR

Model Number	54-0192
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Complainant alleges "this retractor is failing and will not turn when pressure is applied.".
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.

• Brand Name: SYMMETRY® RETRACTOR, ANKENEY STERNAL, ADULT
• Common Device Name: STERNAL RETRACTOR
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 24455147
• Report Number: 3002750084-2026-00018
• Device Sequence Number: 9273733
• Product Code: GAD
• UDI-Device Identifier: 00887482047552
• UDI-Public: 00887482047552
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 54-0192
• Device Lot Number: II533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown