MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCT, INC. BARD-PARKER DISPOSABLE SCALPEL SIZE 15, STERILE; SCALPEL BLADE

Model Number	371615
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant alleges "writer was performing a left 1st toe amputation and was attempting to disarticulate the toe at the metatarsal head joint space when the scalpel blade snapped and broke off, in wound bed.Writer had scalpel blade snap and stopped the procedure and contacted (primary supervisor) and made aware, who came to patient bedside in clinic to assess and attempt to recover scalpel blade.Physician continued to removed toe and was unable to find the remaining scalpel blade in the wound bed.Toe amputation site was dressed with a sterile dressing and xray of left foot was done which revealed the remaining snapped scalpel blade just distal to the left 1st metatarsal bone.A subsequent procedure was needed to remove the retained portion of the blade.".
Additional Manufacturer Narrative
The actual device is not available for evaluation, however the model number and lot number of the device were provided.No pictures were provided.Since no pictures or device were available for evaluation, our ability to investigate was limited.It may have been due to a manufacturing error, or it also may have been due to user error.If it was user error, it could have been due to excessive force being applied to the blade, or twisting or turning the blade under pressure.Final root cause is undetermined.This should be considered the final report.However, if additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: BARD-PARKER DISPOSABLE SCALPEL SIZE 15, STERILE
• Common Device Name: SCALPEL BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCT, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 21268691
• Report Number: 3002750084-2025-00003
• Device Sequence Number: 12912803
• Product Code: GES
• UDI-Device Identifier: 00840113202652
• UDI-Public: 00840113202652
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 371615
• Device Lot Number: 385359
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown