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	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please see below the response sent to the customer.Thank you for bringing this complaint to our attention.Reading through the report states that a carbon sterile sm15 blade has broken during use on an ankle case.Unfortunately, this is the only information we have received, it states that there are no samples available, and the lot number information is also unavailable.With this broken blade falling into the category of an adverse incident it therefore must be reported to the relevant competent authorities.Without having the lot number information, we are unable to check our in-process records to establish if we have experienced any problems during the production process of these blades and we are also unable to check our history to determine if we have received any further complaints of this nature.Due to us not having the broken blade in question returned or blades from the same shelf box or lot number, we are unable to perform a visual inspection and test the heat treatment hardness to ensure the blade has been manufactured to our in-house tolerances and the surgical blade standard bs2982 of which we claim compliance.We hope you will understand that we are finding it difficult to comment further on this broken blade due to not receiving any sample blades to test and no lot number information.If sample blades and lot number information were to become available and returned, we would be able to investigate thoroughly and issue you with a further report of our findings.If we can be of any further assistance, please do not hesitate to contact us.We have been unable to establish how this blade came to break during use on an ankle case due to us not having any sample blades returned to test and no lot number information to check our records.No corrective action is required as we have been unable to establish the root cause of this broken blade due to having no samples returned to test and no lot number information to check our records.No preventive action is required as we have been unable to establish the root cause of this broken blade due to having no samples returned to test and no lot number information to check our records.This was also submitted to the fda under distributor mdr #1423395-2023-00079.
Event or Problem Description
Please see description provided by the healthcare facility."blade breaking during use on an ankle case".

• 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: 18474136
• Report Number: 9611194-2024-00002
• Device Sequence Number: 6572508
• 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): 01/09/2024

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
• 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: 01/05/2024
• Initial Report FDA Received Date: 01/09/2024
• 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