MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. GREENBERG® RETRACTOR, LONG ARM, 9 1/2 IN, 241 MM; GREENBERG RETRACTOR

Model Number	50-1509
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 was returned for evaluation.The part was soaded in instrument milk and then forcibly tightened to be released from the current position.It was discovered that the thumbnut was stuck in the untighten position due to excessive pressure on the drawbar (screw in the middle of the thumbnut) caused by the thumbnut being turned counterclockwise beyond the stop point.The device is now able to function as intended as long as the thumbnut is not overturned.The root cause is customer mishandling.This should be considered the final report.If any additional relevant information is identified it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "(b)(6) has a greenberg arm that they purchased last year is now frozen.Part #50-1509.".

• Brand Name: GREENBERG® RETRACTOR, LONG ARM, 9 1/2 IN, 241 MM
• Common Device Name: GREENBERG 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: 24390908
• Report Number: 3002750084-2026-00017
• Device Sequence Number: 10504681
• Product Code: GZT
• UDI-Device Identifier: 00887482017289
• UDI-Public: 00887482017289
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: 50-1509
• Device Lot Number: R003S361/19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/19/2026
• 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