MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION SHARPOINT; 15 DEGREE MICROKNIFE

Model Number	72-1501
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025, that a blade was dull, intraoperatively.Patient injury occurred which resulted in a delay to surgery.No additional information available.
Additional Manufacturer Narrative
The product was manufactured prior to the implementation of documented corrective actions addressing this known failure mode.An internal investigation was conducted to address the trend associated with the reported event.The following actions were implemented: standardization of the inspection tools and equipment with monitors throughout the manufacturing process replacement of equipment and fixtures to perform penetration testing in all manufacturing areas improvement of the finishing process and documentation.Update set-up and inspection forms as needed this corrective action plan prioritizes improved material handling practices in order to prevent any complications.

• Brand Name: SHARPOINT
• Common Device Name: 15 DEGREE MICROKNIFE
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; no. 24702-b; tijuana baja california 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000; no. 24702-b; tijuana, b.c. 22235 ; MX 22235
• Manufacturer Contact: joseph scoma ; 2755 canyon boulevard, 1st floor; boulder, CO 80302
• MDR Report Key: 23936407
• Report Number: 3010692967-2025-00114
• Device Sequence Number: 9448216
• Product Code: HNN
• UDI-Device Identifier: 00848782027293
• UDI-Public: 00848782027293
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72-1501
• Device Lot Number: E718LJM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown