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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please see below the response sent to the customer, "thank you for bringing your customer complaint to our attention.Reading through the complaint report a carbon sterile sm15 blade has broken in half during use.Unfortunately, the procedure that was being performed has not been specified.It also states that sample blades are not available to be returned for us to test.Without having the broken blade in question returned or sample blades from the same shelf box or lot number we are unable to perform the relevant tests for this investigation to ensure the blade had been manufactured to the surgical blade standard bs 2982 of which we claim compliance.We are also obligated to report this to the relevant competent authorities as it falls into the category of an adverse incident due to the blade breaking during use.Using the above lot number, we have checked our in-process records and we have been unable to identify any problems that could help us with this broken blade.We can also inform you that we have received no further complaints of this nature and we produced and sold (b)(4).Carbon sterile sm15 blades.With us not knowing the procedure that was being performed at the time of the breakage and with us not receiving any sample blades to test, we are finding it difficult to comment further.If this information and sample blades were to become available, we would be able to perform the relevant heat treatment hardness tests and provide you with another more detailed report of our findings.Once again thank you for bringing this to our attention and if we can be of any further assistance, please contact us without hesitation.Due to us not receiving the information of what procedure was being performed at the time of the breakage and with us having no sample blades returned to test, we have been unable to identify the root cause of this broken blade.With us not being able to identify the root cause of this broken blade due to the reasons mentioned above, we believe no corrective action is required.With us not being able to identify the root cause of this broken blade due to the reasons mentioned above, we believe no preventive action is required.".
Event or Problem Description
Please see the description provided by the healthcare facility, "blade broke in half - physician was using to create an incision, procedure not specified".

• Brand Name: SWANN-MORTON NO.15 CARBON STERILE BLADES
• Common Device Name: SCALPEL BLADE
• Manufacturer (Section D): SWANN MORTON LTD.; owlerton green; sheffield, , gb S6 2B J; UK S6 2BJ
• Manufacturer (Section G): SWANN MORTON LTD.; owlerton green; sheffield, , gb S6 2B J; UK S6 2BJ
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 17750691
• Report Number: 9611194-2023-00005
• Device Sequence Number: 7210299
• Product Code: GES
• UDI-Device Identifier: 05033955002053
• UDI-Public: 05033955002053
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/14/2023

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: 3772304
• 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: 09/05/2023
• Initial Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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