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

Model Number	NO. 15 STAINLESS 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	05/03/2024
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 which states that a stainless sterile sm15 blade has shredded during a craniotomy procedure.Thank you for providing the photograph of what appears to be three little pieces of broken blade in the brain.We are glad to hear no serious injury was reported at this time.With this blade breaking during this surgical procedure, it falls into the category of an adverse injury and as such must be reported to the relevant authorities.Unfortunately, it does state that the blade in question or sample blades from the same lot number or not available for us to test.Without having sample blades returned we are unable to check the heat treatment hardness on our calibrated hardness testing machine to ensure the blade had been manufactured to our in-house tolerances and the surgical blade standard bs 2982.With you providing us with this lot number, we can inform you that with the use of our in-process records, we have no problems recorded during production that could be linked to this broken blade.We have also checked our records and to the best of our knowledge, we have received no further customer complaints of this nature of which (b)(4) stainless 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 due to not having the blade in question or any sample blades to test.The only explanation we can offer is our surgical blades are designed for the cutting of soft tissue and if the blade was being used in the scull this could have caused the pieces to break off.If the blade in question or sample blades did become available and returned, we would be able to perform the relevant tests for this investigation and issue you with a further 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 these little pieces of the blade had broken off due to not having the blade in question returned or sample blades to test.We believe no corrective action is required as we have been unable to establish the root cause due to not having any sample blades returned to test.We believe no preventive action is required as we have been unable to establish the root cause due to not having any sample blades returned to test.".
Event or Problem Description
The following description was provided by the healthcare facility, "blade shredded during procedure".It was stated that, "no serious injury was reported at this time".

• Brand Name: SWANN-MORTON NO. 15 STAINLESS 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: 19526888
• Report Number: 9611194-2024-00011
• Device Sequence Number: 20759191
• Product Code: GES
• UDI-Device Identifier: 05033955003050
• UDI-Public: 05033955003050
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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 STAINLESS STERILE BLADES
• Device Catalogue Number: 0305
• Device Lot Number: 4922310
• 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: 06/05/2024
• Initial Report FDA Received Date: 06/13/2024
• 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