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

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	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please see below the response sent to the customer, "thank you for bringing this latest complaint to our attention where a carbon sterile sm15 blade has broken during use.Unfortunately, this is the only information that is available for this complaint.There is no lot number, no sample, no information on the procedure in question, or how the blade came to break.Without the relevant information or having samples returned for us to test, we are unable to perform an investigation into this complaint.If the blade in question or samples from the same shelf box or lot number, the relevant information we require were to become available, we would be able to investigate and issue you with a report of our findings.We hope you will understand we can't comment further but if you require 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 received no samples or any information to perform an investigation.No corrective action is required as we have been unable to establish the root cause due to not receiving any samples or information to investigate.No preventive action is required as we have been unable to establish the root cause due to not receiving any samples or information to investigate." as we were not proved with a lot number or any sample of the device that was broken, we were unable to carry out a full investigation with this lack of information.We were informed that no further details were to be provided and therefore consider this matter to be closed.
Event or Problem Description
The description provided by the healthcare facility was as follows: "blade broke during use".

• Brand Name: SWANN-MORTON NO. 15 CARBON STERILE BLADES
• Common Device Name: BLADE, SCALPEL
• 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: 17884876
• Report Number: 9611194-2023-00007
• Device Sequence Number: 15178750
• Product Code: GES
• UDI-Device Identifier: 05033955002053
• UDI-Public: 05033955002053
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/06/2023

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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