MAUDE Adverse Event Report: SWANN MORTON LTD. SWANN-MORTON NO. 11P CARBON STERILE BLADES; SCALPEL BLADE

Model Number	NO. 11P CARBON STERILE BLADES
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 september 2024.The following response was provided to the customer: thank you for informing our sales department of your customer complaint.From the report, we are led to believe that a carbon sterile sm11p blade has broken during a laparoscopic procedure.With this blade breaking during use, we must report it to the relevant competent authorities as it falls into the category of an adverse incident.Unfortunately, it states that no sample blades are available to be returned.We are aware that this is the second broken blade complaint we have received from you regarding a carbon sterile sm11p on the above lot number.We received the first one on 30th september 2025, ref no.2025-00271405-1, stating the blade had broken inside a patient during use.With this complaint, we did receive the broken blade in question, and when tested, the heat treatment hardness was over 800hv, proving the blade had been manufactured to the surgical blade standard bs2982, of which we claim compliance.With us having no sample blades returned for this complaint, we are unable to perform the relevant tests to conclude this investigation, but by using this lot number, this has enabled us to check our in-process records, where no deviations could be found during the manufacturing process of these blades.We can also inform you that apart from your previous complaint listed above, we have received no further customer complaints of this nature, of which (b)(4) carbon sterile sm11p blades were produced and sold on this lot number.We hope you will understand that without the blade in question or sample blades from the same shelf box or lot number, it is difficult to provide you with further information.If sample blades were to become available and returned, we would be able to perform the relevant tests and issue 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 how this blade broke during a laparoscopic procedure, as we have not received the blade in question or sample blades to test.No corrective action is required as we have been unable to establish the root cause.This is because the broken blade in question or any sample blades are not available to be returned and tested.No preventive action is required as we have been unable to establish the root cause.This is because the broken blade in question or any sample blades are not available to be returned and tested.
Event or Problem Description
The healthcare facility provided the following information."a no.11p carbon sterile blades had broken during a laparoscopic procedure".No further information was provided relating to the patients health effects.Distributor report no.(b)(4); (medline).

• Brand Name: SWANN-MORTON NO. 11P 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: 23776532
• Report Number: 9611194-2025-00012
• Device Sequence Number: 10083842
• Product Code: GES
• UDI-Device Identifier: 05033955002916
• UDI-Public: 05033955002916
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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. 11P CARBON STERILE BLADES
• Device Catalogue Number: 0291
• Device Lot Number: 4632409
• 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: 12/04/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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
• Patient Sex: Unknown