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 Fracture (1260)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

Please see below response sent to the customer, thank you for informing us of your customer complaint where a carbon sterile sm11p blade has broken during a knee arthroscopy procedure.As you are aware with this blade breaking during a surgical procedure, we are obligated to report this to the relevant competent authorities as it does fall into the category of an adverse incident.Thank you also for trying to obtain as much information as possible as it is vital to this type of complaint, and reading through the report it does state no sample blades are available at this stage for testing.If sample blades were to become available and returned, we would be able to perform the relevant heat treatment hardness tests to ensure the blades had been manufactured to our in-house tolerances and the surgical blade standard bs 2982.We would then be able to issue you with a further report detailing our findings.Using this lot number, we have checked through our in-process records for the manufacturing process of these blades, and we can inform you that we have no problems recorded that could assist us with this complaint, we can also inform you that to the best of our knowledge, we have received no further customer complaints regarding blades breaking and of which we produced and sold 45,400carbon sterile sm11p blades on this lot number.We hope you will understand that it is difficult for us to comment further due to not receiving any sample blades for us to test and 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 a knee arthroscopy as the blade in question is not available for testing or sample blades from the same shelf box or lot number.We believe no corrective action is available as we have been unable to establish the root cause due to having no sample blades returned.We believe no preventive action is available as we have been unable to establish the root cause due to having no sample blades returned.

Event Description

Please see response received from the healthcare facility."blade, #11p breaking off in the patients during a knee arthroscopy procedure".It was stated by the healthcare facility that, "the procedure was not delayed and all pieces were retrieved".It was also stated that no injury occurred to the patient.

• 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: 18743544
• MDR Text Key: 336763501
• Report Number: 9611194-2024-00003
• Device Sequence Number: 1
• Product Code: GES
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• 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: 4732209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• 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