MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. FLEXIBLE ADAPTOR - DRAEGER POLARIS 100/200; LIGHT HANDLE ADAPTOR

Model Number	LT-9687X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "the screw was broken and the adaptor came off.".
Additional Manufacturer Narrative
The device has been returned for evaluation, and the investigation is ongoing.Once we have additional relevant information it will be submitted in a supplemental report.
Additional Manufacturer Narrative
The device was returned for evaluation, however no lot number was provided.The investigation shows the screw broke off at the transition between the unthreaded adaptor hole and the threaded insertion hole on the light handle.It is impossible to determine exactly what force contributed to the breaking of the screw.Review of the adaptor itself shows all measurements surrounding the screw insertion point to be within specification, indicating no issue with the fit of the adaptor in relation to a screw.The screw was confirmed to be the correct size.The root cause for why the screw broke and what force caused it cannot be determined.It could be a defect within the light handle, stripping of the inside threads dur to overtightening, or a number of other reasons that led to the breaking of the screw.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: FLEXIBLE ADAPTOR - DRAEGER POLARIS 100/200
• Common Device Name: LIGHT HANDLE ADAPTOR
• 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: 24272773
• Report Number: 3002750084-2026-00008
• Device Sequence Number: 18649713
• Product Code: FTA
• UDI-Device Identifier: 00840113208395
• UDI-Public: 00840113208395
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: LT-9687X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/27/2026
• 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