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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The description provided by the healthcare facility was as follows, "the #11 blade broke".No remedial actions were stated.Further information was requested by the manufacturer to the healthcare facility however no further information was provided.
Additional Manufacturer Narrative
The following response was sent to the customer, "thank you for informing us of your customer complaint where a carbon sterile sm11p has broken during use.Unfortunately, we have been issued with no further information including the procedure that the blade was used in and the original lot number that was quoted on the scar has been confirmed as wrong.The delay in issuing this report has been due to us waiting for the broken blade in question and another unbroken sample blade for us to investigate.Firstly, we had to process both blades through our irradiation facility to ensure they were safe to handle, and we were then able to perform a visual inspection and test the heat treatment hardness on our calibrated hardness testing machine to ensure it was in compliance with bs 2982 of which we manufacture in accordance with.The heat treatment hardness of both blades was over 800hv identifying the blades complied with bs 2982.We then tested the ductility of the unbroken blade on our automated loadcell which provided us with acceptable results, an image of this has been included with this report.Using the above lot number, we have checked our in-process records and we have been unable to find any recorded problems that could be linked to this broken blade.We have checked our history and from 39,200 carbon sterile sm11p blades manufactured on this lot number to the best of our knowledge, we have received no further complaints of this nature.Once again thank you for returning the broken blade in question and the unbroken used blade for us to investigate but we have been unable to find fault with the results through our investigation.With us receiving no information including the procedure that the blade was used in, we are finding it difficult to comment further on how this blade broke.If further information was provided to us, we would investigate and issue 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 been unable to find fault with the two returned blades through our investigation.No corrective action is required as we were unable to find fault with the two returned blades through our investigation.No preventive action is required as we were unable to find fault with the two returned blades through our investigation.".

• 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: 19237086
• Report Number: 9611194-2024-00008
• Device Sequence Number: 8034548
• Product Code: GES
• UDI-Device Identifier: 05033955002916
• UDI-Public: 05033955002916
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/03/2024

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. 11P CARBON STERILE BLADES
• Device Catalogue Number: 0291
• Device Lot Number: 4282306
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (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