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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following response was sent to the customer, "thank you for informing us of your customer complaint where a carbon sterile sm15 blade has broken during a lower extremity procedure.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 that the blade in question or sample blades are not available to be returned.Without sample blades, we are unable to check the heat treatment hardness on our calibrated hardness testing machine to establish if the blade had been manufactured to our in-house tolerances and the surgical blade standard bs 2982.If we were to receive unopened samples from the same shelf box or lot number, we would also check the ductility of the blade on our automated load cell.With you providing us with the above lot number, we have checked our history and to the best of our knowledge, we have received no further complaints regarding blades breaking during use and we produced and sold (b)(4) carbon sterile sm15 blades on this lot number.We can also inform you that we have no problems recorded through our in-process records that could be connected to this complaint.We hope you will understand that we are finding it difficult to comment further as we have no sample blades to test, if the blade in question or sample blades were returned, we will 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 broken blade as we have not received the broken blade in question or sample blades from the same shelf box or lot number to test.No corrective action is required as we have been unable to establish the root cause of this broken blade due to not receiving sample blades to test.No preventive action is required as we have been unable to establish the root cause of this broken blade due to not receiving sample blades to test.".
Event or Problem Description
The following description was provided by the healthcare facility, "component broke when surgeon went to make an incision on the patient".

• 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: 20117022
• Report Number: 9611194-2024-00016
• Device Sequence Number: 20657103
• Product Code: GES
• UDI-Device Identifier: 05033955002053
• UDI-Public: 05033955002053
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/30/2024

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: 5192311
• 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: Not provided
• Initial Report FDA Received Date: 09/02/2024
• 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