MAUDE Adverse Event Report: SWANN MORTON LTD. SWANN-MORTON NO.15 CARBON STERILE BLADES; SCALPEL BLADE

Model Number	BLADE,SCALPEL, SINGLE USE.
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please see below the response sent to the customer.Thank you for informing us of your customer complaint where a carbon sterile sm15 blade broke in half during a nasal procedure and injured the patient's lip.The delay in issuing this report has been due to us waiting for further information to assist this investigation, but after an internal discussion and no further information has been received, we have decided to answer this complaint using the above lot number and the limited information we have received.With this blade breaking during use, we are obligated to report this to the relevant competent authorities as it falls into the category of an adverse incident.Unfortunately, it does state on the report that sample blades are not available for us to test, without sample blades we are unable to test the blade's heat treatment hardness to ensure this blade had been manufactured to the surgical blade standard bs 2982 of which we claim compliance.Using the above lot number, we can inform you that all in-process records have been checked for the relevant departments during the manufacturing process of these blades and no problems have been identified that could be connected to this complaint, we have also checked our history and to the best of our knowledge, we have received no further complaints of this nature of which 449,700 carbon sterile sm15blades were produced and sold on this lot number.We hope you will understand that it is difficult for us to comment further due to us receiving limited information and no sample blades to test.If the broken blade in question or any sample blades from the same shelf box or lot number were to become available and returned, we would be able to perform the relevant tests and issue you with a follow-up report detailing our findings.If we can be of any further assistance, please do not hesitate to contact us.We have been unable to establish the root cause of this broken blade complaint as we have received limited information and no sample blades for us to investigate.No corrective action is required as we have been unable to establish the root cause of this complaint due to receiving limited information and having no sample blades to investigate.No preventive action is required as we have been unable to establish the root cause of this complaint due to receiving limited information and having no sample blades to investigate.
Event or Problem Description
The following description was provided by healthcare facility."a #15 knife blade in one of our packs broke in half when a surgeon made his incision.The surgery was a nasal procedure, and when the blade broke in half it caused an injury to the patients lip".

• Brand Name: SWANN-MORTON NO.15 CARBON STERILE BLADES
• Common Device Name: SCALPEL BLADE
• Manufacturer (Section D): SWANN MORTON LTD.; owlerton green; penn works; sheffield, S6 2B J; UK S6 2BJ
• Manufacturer (Section G): SWANN MORTON LTD.; owlerton green; penn works; sheffield, S6 2B J; UK S6 2BJ
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7202545756
• MDR Report Key: 21159631
• Report Number: 9611194-2025-00001
• Device Sequence Number: 12670289
• Product Code: GES
• UDI-Device Identifier: 05033955002053
• UDI-Public: 05033955002053
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2025

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: BLADE,SCALPEL, SINGLE USE.
• Device Catalogue Number: 0205
• Device Lot Number: 3622403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 01/15/2025
• 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
• Patient Sex: Unknown