MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. VERITY NERVE HOOK TITANIUM HANDLE, 3.0 MM

Model Number	80-1531
Medical Device Problem Code	Break (1069)
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 device broke in the area where the probe was bent during production.When items are bent, there is an increase in the stress concentration in the area of the bend.As a result, the tip of the proce is susceptible to fracturing under excessive force.The root cause is user error for using excessive force on the instrument.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 "i have a customer (b)(6) ifs- (b)(6) that is requesting a quality review for two instruments that they have had that are reported to have broken during a procedure.No patients were harmed, but the same catalog number has broken twice, so they wanted us to look into it.".

• Brand Name: VERITY NERVE HOOK TITANIUM HANDLE, 3.0 MM
• Common Device Name: NERVE HOOK
• 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: 24430711
• Report Number: 3002750084-2026-00023
• Device Sequence Number: 21393414
• Product Code: GDG
• UDI-Device Identifier: 00887482031070
• UDI-Public: 00887482031070
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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: 80-1531
• Device Lot Number: 932747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/24/2026
• 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