MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BERKETTE BEACH CHAIR LIMB POSITIONER; PATIENT POSITIONING

Model Number	711200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "this morning we had the handle on the berkette break off while getting the patient positioned.This happened 3 times to 3 different products all with the same lot# of 110525.Hopefully you can tell from the pictures below, but the handle snapped where it is covered by the grip.".
Additional Manufacturer Narrative
The device was not returned for evaluation, but pictures were provided so the complaint could be confirmed.The investigation concluded that the breakage of the bracket handle was due to a devication attributable to the external supplier that provides this component.The supplier was notified, and corrective actions are being followed up.The root cause is a manufacturing error.This should be considered the final report.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: BERKETTE BEACH CHAIR LIMB POSITIONER
• Common Device Name: PATIENT POSITIONING
• 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: 24981539
• Report Number: 3002750084-2026-00041
• Device Sequence Number: 9642355
• Product Code: CCX
• UDI-Device Identifier: 00840113230662
• UDI-Public: 00840113230662
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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: 711200
• Device Lot Number: 110525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown