MAUDE Adverse Event Report: SWANN-MORTON LTD SWANN MORTON NO. 10 BLADE; SCALPEL BLADE

Model Number CARBON STEEL SM 10

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/13/2022

Event Type  malfunction  

Event Description

The following is the description from the healthcare facility, "(b)(6) just told me that in (b)(6) cases both basin packs a knife blade broke on two while being used.A #10 on one case and a #15 on the other.Luckily, they were not retained in the patient.So the lot # will need to be looked at and the blades not used in those packs.So no more knife blades separately." it was stated that the following component name was, "blade,#10,carbon steel,surgical,swann morton,foil,st".

Manufacturer Narrative

Unfortunately we are unable to perform an investigation at this time without further information being provided by the healthcare facility, which has been requested upon receiving the complaint.Once we have received the relevant information, we will complete further investigation into the lot number of the device and associated testing of the device/unopened devices from the same lot.Below is the response sent to the customer: thank you for informing us of your customer complaint regarding a carbon sterile sm10 blade breaking in two whilst being used.With this blade breaking during a procedure, we are obligated to report this to the relevant competent authorities as it falls into the category of an adverse incident.With this type of complaint, for us to perform a thorough investigation we must have the broken blade in question returned or blades from the same lot number or shelf box to test.We also need the lot number to enable us to check our in-process records and our history to see if we have received any further complaints of this nature.If we were to have had samples returned, we would have been able to check the blade's heat treatment hardness on our calibrated hardness testing machine and the blade's ductility on our automated load cell to ensure it had been manufactured to our in-house tolerances and the surgical blade standard bs 2982 of which we claim compliance.We hope you will understand it is difficult for us to comment further due to having no samples or lot number information.It does state in the component name of the complaint report that the blade in question is a carbon steel sm10 but reading through the description it also mentions a 15 blade.We have been informed that no further information or samples are available.If these were to become available in the future and returned, we would be able to perform a thorough investigation and issue you with a furthermore detailed report of our findings.If we can be of any further assistance, please do not hesitate to contact us.Root cause the root cause of this broken blade could not be established as we have no sample blades returned to test and no lot number information to check our in-house records and history.Corrective action no corrective action is required as we were unable to establish the root cause of this broken blade.Preventive action no preventive action is required.

• Brand Name: SWANN MORTON NO. 10 BLADE
• Type of Device: SCALPEL BLADE
• Manufacturer (Section D): SWANN-MORTON LTD; owlerton green; sheffield, 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: 15377324
• MDR Text Key: 305535498
• Report Number: 9611194-2022-00002
• Device Sequence Number: 1
• Product Code: GES
• UDI-Device Identifier: 05033955002015
• UDI-Public: 05033955002015
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/08/2022

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: CARBON STEEL SM 10
• Device Catalogue Number: 0201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1