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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
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 septoplasty procedure.As this complaint falls into the category of an adverse incident, it must be reported to the relevant competent authorities.Reading through the complaint report, no sample is available available for us to test.Without having the blade in question returned or sample blades from the same lot number, we are unable to test the heat treatment hardness on our calibrated hardness testing machine to ensure the blade has been manufactured to our in-house tolerances and the surgical blade standard bs 2982.Using the above lot number, we have been able to check our in-process records and we have no problems recorded that could assist us with this broken blade.To the best of our knowledge, we have received no further customer complaints of this nature of which (b)(4) carbon sterile sm15 blades were produced and sold on this lot number.We hope you will understand that it is difficult for us to comment further on how this blade broke during a septoplasty procedure, the only explanation we can offer is if the blade was in or around the cartilage and bone and excessive twisting or lateral pressure was applied this could have contributed to the blade breaking.If the blade in question or sample blades do become available and returned, we will be able to perform a full investigation 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 how this carbon sterile sm15 broke during use as we have not received the blade in question or sample blades from the same lot number to test.No corrective action is required as we have been unable to establish the root cause due to us not receiving any sample blades to test.No preventive action is required as we have been unable to establish the root cause due to us not receiving any sample blades to test.".
Event or Problem Description
The following description of the incident was provided by the healthcare facility, "blade #15 was broken during use.No patient or staff injury.No other details and happened once only".No remedial actions were stated by the healthcare facility, although it was stated that there was "no patient injury or staff injury", and that it "only happened once".

• 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: 19355304
• Report Number: 9611194-2024-00009
• Device Sequence Number: 7510092
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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: 4912310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/20/2024
• 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