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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following our investigation we now consider this matter to be closed.As no lot number was provided we could not carry out a thorough investigation.If any information does become available after the submission of this report then a follow up report shall be issued.The following response was sent to the customer, "thank you for informing our sales department of your customer complaint.Reading through the complaint report, we are led to believe that a carbon sterile sm10 blade has broken in half during a total knee procedure.Unfortunately, without having any lot number information or the broken blade in question or sample blades from the same lot number to investigate, we are finding it difficult to perform any sort of investigation into this complaint, and because this blade has broken during a surgical procedure, we must report this to the relevant competent authorities as it falls into the category of an adverse incident.Without having any sample blades returned to test, we are unable to check the heat treatment hardness to ensure the blade had been manufactured to our in-house tolerances and the surgical blade standard bs 2982.With unbroken samples from the same lot number, we would also be able to check the ductility on our automated load cell.With you not being able to inform us of the lot number, we are unable to check our in-process records for any recorded problems during the manufacturing process or to check our history to establish if we have received any further customer complaints of this nature.We hope you will understand that we cannot comment further due to not having sample blades or lot number information to investigate, if these were to become available, we would perform a thorough 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 unsuccessful in finding the root cause of this broken blade as we have received very little information and no sample blades to investigate.No corrective action is required as we have been unable to establish the root cause due to receiving very little information and no sample blades to investigate.No preventive action is required as we have been unable to establish the root cause due to receiving very little information and no sample blades to investigate.".
Event or Problem Description
The following description of the incident was provided by the healthcare facility, "breaking in half during use".No remedial actions were stated by the healthcare facility.It was stated that the procedure was not delayed due to the issue.

• 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: 19355316
• Report Number: 9611194-2024-00010
• Device Sequence Number: 18046907
• Product Code: GES
• UDI-Device Identifier: 05033955002015
• UDI-Public: 05033955002015
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• 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. 10 CARBON STERILE BLADES
• Device Catalogue Number: 0201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• 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