MAUDE Adverse Event Report: SWANN MORTON LTD. SWANN-MORTON NO. 11P CARBON STERILE BLADE; SCALPEL BLADE

Model Number NO. 11P CARBON STERILE BLADE

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  malfunction  

Event Description

Please see response provided from the healthcare facility."no.11p blade broke while performing a shoulder arthroscopy, the patient is fine".

Manufacturer Narrative

Please see below the response sent to the customer.Thank you for informing us of your customer complaint.Reading through the complaint report it states that a carbon sterile sm11p blade has broken inside the patient during a shoulder arthroscopy.As you are aware with this blade breaking during use,we are obligated to report this to the relevant competent authorities as it falls into the category of an adverse incident.Unfortunately, it does state that sample blades are not available, without the blade in question or sample blades from the same shelf box or lot number, we are unable to perform the relevant tests for our investigation.We need to test the blade's heat treatment hardness on our calibrated hardness testing machine to ensure the blade has been manufactured to our in-house tolerances and the surgical blade standard bs 2982.If we were to get unbroken blades returned from the same shelf box or lot number, we would also check the ductility of the blade on our automated load cell.With you providing us with a lot number, we have checked our history and to the best of our knowledge, we have received no further customer complaints regarding blades breaking, and of which we produced and sold (b)(4) carbon sterile sm11p blades on this lot number.We have checked our in-process records throughout the production of these blades, and we have no problems recorded that could be linked to this complaint.We hope you will understand that it is difficult for us to comment further due to us not having any sample blades to test.If in the future you were able to return sample blades for us to test, we would be able to perform the relevant tests and issue you another report detailing our findings.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 not received the broken blade in question or sample blades from the same shelf box or lot number for us to test.We believe no corrective action is required as we have been unable to establish the root cause due to us not receiving the blade in question or sample blades to test.We believe no preventive action is required as we have been unable to establish the root cause due to us not receiving the blade in question or sample blades to test.

• Brand Name: SWANN-MORTON NO. 11P CARBON STERILE BLADE
• Type of Device: 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: 18845538
• MDR Text Key: 337854279
• Report Number: 9611194-2024-00005
• Device Sequence Number: 1
• Product Code: GES
• UDI-Device Identifier: 05033955002916
• UDI-Public: 05033955002916
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2024

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
• Device Operator: Health Professional
• Device Model Number: NO. 11P CARBON STERILE BLADE
• Device Catalogue Number: 0291
• Device Lot Number: 3802304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1