MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. KARLIN HOOK, MICRO NERVE, 8 1/2 IN

Model Number	46-3171
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	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are in process of trying to get the device returned for evaluation and to get more information from the reporter.The investigation is ongoing.Once we have additional relevant information it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "micro nerve hook tip 46-3171 broke off during surgical procedure.".
Additional Manufacturer Narrative
The device was not returned for evaluation, and no lot number was able to be obtained.Due to lack of information, the complaint could not be confirmed and very little investigation could be performed.Complaint history did not reveal any prior similar complaints from the past two years.Root cause was undetermined.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: KARLIN HOOK, MICRO NERVE, 8 1/2 IN
• Common Device Name: KARLIN 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: 24281251
• Report Number: 3002750084-2026-00010
• Device Sequence Number: 13212185
• Product Code: GDG
• UDI-Device Identifier: 00887482014851
• UDI-Public: 00887482014851
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 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: 46-3171
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 41 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: White