MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. ELEVATOR, PRESBYTERIAN HOSP, CURVED, DOUBLE ENDED; SURGICAL ELEVATOR

Model Number	65-1006
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Complainant alleges "pin fell off the device and into the patient, and staff was able to retrieve it.".
Additional Manufacturer Narrative
The device was returned for evaulation.After evaluation of the parts that were returned, there is an imperfection in the pin insert weld area.The drawing file was reviewed and per the drawing notes the welded tungsten carbide inserts shall be smooth without weld pits and/or joint gaps.The parts showed joint gaps in the insert area, and the root cause is manufacturing error linked to the production processing during the welding and/or finishing phase.This lot was produced by a supplier which no longer makes this product for us, and newer lots (from current suppleir) were checked and found to be made correctly.The current vendor was made aware of the complaint to help prevent recurrence.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: ELEVATOR, PRESBYTERIAN HOSP, CURVED, DOUBLE ENDED
• Common Device Name: SURGICAL ELEVATOR
• 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: 24758576
• Report Number: 3002750084-2026-00038
• Device Sequence Number: 15639338
• Product Code: GEG
• UDI-Device Identifier: 00887482025239
• UDI-Public: 00887482025239
• 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): 05/07/2026

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: 65-1006
• Device Lot Number: 163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/07/2026
• 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