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

Model Number NO. 11P CARBON STERILE BLADES

Device Problem Material Integrity Problem (2978)

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

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

The healthcare facility reported this incident to the fda on 26th july 2023 and given the reference number: (b)(4).Please see below the response sent to the customer, "thank you for informing us of your customer complaint where a carbon sterile sm11p has broken during an arthroscopy procedure.With this blade breaking during the above procedure, we must report this to the relevant competent authorities as it falls into the category of an adverse incident.Thank you for returning the broken blade in question and the unopened sm11p from the same lot number for us to test.Firstly, we had to process the broken blade through our gamma irradiation facility to ensure it was safe to handle.We then checked the heat treatment hardness of the broken blade and the unused blade on our calibrated hardness testing machine where we achieved results of 837hv on both blades indicating they had been manufactured to our in-house tolerances and the surgical blade standard bs2982.Using the unused blade, we were then able to test the ductility on our automated load cell where we were able to achieve an acceptable bend.With this lot number, we have been able to check our in-process records for any recorded problems that could assist this complaint, and none could be found, we can also inform you that we have received no further customer complaints regarding blades breaking of which (b)(4) carbon sterile sm11p were produced and sold.Using the results from the above tests the only explanation we can offer is with this blade breaking during arthroscopy surgery if any excessive twisting or lateral pressure was applied in or around the joint this could have contributed to the blade breaking.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 were unable to find fault with the broken blade in question and the sample blade.The only explanation we can offer is the one mentioned above.No corrective action is required as we were unable to find fault with the broken blade in question through our investigation.No preventive action is required as we were unable to find fault with the broken blade in question through our investigation.".

Event Description

Please find the description provided by the healthcare facility, "blade broke during use - broke in half and the incident added an hour to the surgical case in order to locate the tip of the blade in the patient".

• Brand Name: SWANN-MORTON NO. 11P CARBON STERILE BLADES
• 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: 17559412
• MDR Text Key: 321338166
• Report Number: 9611194-2023-00004
• 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: 08/16/2023

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
• Device Operator: Health Professional
• Device Model Number: NO. 11P CARBON STERILE BLADES
• Device Catalogue Number: 0291
• Device Lot Number: 3672303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1