MAUDE Adverse Event Report: SWANN MORTON LTD. SWANN-MORTON NO. 10 CARBON STERILE BLADES; SCALPEL BLADE

Model Number	NO. 10 CARBON STERILE BLADES
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following description was provide by the healthcare facility."while the physician was using the sm10 blade it broke during the procedure and was retrieved from the patient.No injury reported".
Additional Manufacturer Narrative
Thank you for informing us of your customer complaint where a carbon sterile sm10 blade has broken during a surgical procedure.At this stage, we are unsure of the procedure that was being performed at the time of the breakage, as we have not received that information, but this does fall into the category of an adverse incident and must be reported to the relevant competent authorities.Unfortunately, the blade in question or sample blades from the same shelf box or lot number are not available for us to test.Without having the blade in question, we are unable to check the heat treatment hardness to ensure the blade has been manufactured to the surgical blade standard bs 2982, of which we claim compliance.With you providing us with the lot number, we have been able to check our in-process records from a department level for any deviations that could have occurred during production.We can confirm none were found.We have also checked our history, where we have received no further complaints of this nature, of which 215,000 carbon sterile sm10 blades were produced and sold on this lot number.We hope you will understand that it is difficult to provide you with any further information due to no sample blades being returned and the lack of information we have received.If these were to become available in the future, we would investigate further 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, as we have no sample blades to test, and we are unsure of the procedure that was being performed at the time of the breakage.No corrective action is required as we have been unable to establish the root cause due to the lack of information provided, and no sample blades have been returned.No preventive action is required as we have been unable to establish the root cause due to the lack of information provided, and no sample blades have been returned.The date of manufacture was unable to be entered, however as the healthcare facility provided the lot number we were able to identify that the device was manufactured in may 2024.When entering similar incidents these have been stated as 0 for all four years, as despite numerous attempts to find out the procedure being performed this information was not provided.

• Brand Name: SWANN-MORTON NO. 10 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: 23070301
• Report Number: 9611194-2025-00010
• Device Sequence Number: 9719760
• Product Code: GES
• UDI-Device Identifier: 05033955002015
• UDI-Public: 05033955002015
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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 Expiration Date: 05/31/2025
• Device Model Number: NO. 10 CARBON STERILE BLADES
• Device Catalogue Number: 0201
• Device Lot Number: 3962405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 09/17/2025
• 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