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

Model Number	NO.15 CARBON STERILE BLADES
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following description was provided by the healthcare facility."the resident was performing surgery on the patients left foot (podiatry case) when the knife blade broke in half.She was able to take the piece out immediately".The following remedial actions were stated by the healthcare facility."she was able to take the piece out immediately.Xray will be taken at the end of the case due to the nature of the case".
Additional Manufacturer Narrative
The following response was provided to the user facility: thank you for informing us of your customer complaint, where a carbon sterile sm15 blade has broken in half whilst performing surgery on the patient's left foot.With this blade breaking during a surgical procedure, it falls into the category of an adverse incident and therefore must be reported to the relevant competent authorities.We were initially made aware of this complaint via our us representative, as it had already been reported to the us fda.We have been awaiting the blade in question or sample blades to be returned, but we have now been informed that the blade was discarded the day of the surgery.Without the blade in question or sample blades from the same shelf box or lot number, we are unable to test the heat treatment hardness on our calibrated hardness testing machine to ensure the blade had been manufactured to the surgical blade standard bs2982, of which we claim compliance.With you providing us with a lot number, we have been able to check our in-process records during the production of these blades, and we have been unable to identify any information to suggest we have had any problems or deviations that we could connect to this complaint.We have also checked our history, and we can inform you that we have received no further complaints of this nature, and we produced and sold743,500 carbon sterile sm15 blades on this lot number.We hope you will understand that we are unable to provide you with any further information due to not having the blade in question or sample blades returned to investigate.If these were to become available and returned, we would be able to perform the relevant tests and issue you with a follow-up report.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 complaint as we have not had the blade in question or sample blades returned for us to investigate.No corrective action is required as we have been unable to establish the root cause due to not having sample blades to test.No preventive action is required as we have been unable to establish the root cause due to not having sample blades to test.

• 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: 22411340
• Report Number: 9611194-2025-00009
• Device Sequence Number: 12863759
• Product Code: GES
• UDI-Device Identifier: 05033955002053
• UDI-Public: 05033955002053
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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: NO.15 CARBON STERILE BLADES
• Device Catalogue Number: 0205
• Device Lot Number: 5112411
• 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: 06/24/2025
• Initial Report FDA Received Date: 07/07/2025
• 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 Age: 51 YR
• Patient Sex: Unknown