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

Model Number	NO. 15 CARBON STERILE BLADES
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following description was provided by the healthcare facility, "blade broke off in the patient has some of it was never found" "multiple hand packs with 15 blades have been broke multiple times just using a needle holder to place it on a knife handle.Blades are breaking off in preparation for and during surgeries." although it was stated that part of the blade broke in the patient and was never found, it was also stated that no injury occurred.
Additional Manufacturer Narrative
The following response was sent to the customer, "thank you for informing us of your customer complaint where, reading the description a carbon sterile sm15 blade has broken in a patient.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, we have received very little information, and the blade in question or sample blades from the same box or lot number are not available for us to test.With limited information on how this blade came to break and not having any sample blades to test the heat treatment hardness to establish if the blade has been manufactured to the surgical blade standard bs 2982, we are finding it difficult to perform any sort of investigation.With you providing us with a lot number, we can inform you that we have no problems recorded throughout our in-process records that could be connected to this broken blade, and to the best of our knowledge, we have received no further customer complaints of this nature and we produced and sold 558,400 carbon sterile sm15 blades on this lot number.We hope you will understand that we are unable to comment further due to us receiving very limited information and no sample blades to test.If further information or samples were to be returned, we could perform a thorough investigation and issue you with a follow-up report.If we can be of any further assistance, please do not hesitate to contact us.We have been unable to establish how this blade broke during use as we have received very little information to investigate and no sample blades to test.No corrective action is required as we have not been able to establish the root cause due to receiving very little information about how the blade broke and no sample blades returned to test.No preventive action is required as we have not been able to establish the root cause due to receiving very little information about how the blade broke and no sample blades returned to test.".

• Brand Name: SWANN-MORTON NO. 15 CARBON STERILE BLADES
• Common Device Name: SCALPEL BLADE
• Manufacturer (Section D): SWANN MORTON LTD.; owlerton green; penn works; sheffield, S6 2B J; UK S6 2BJ
• Manufacturer (Section G): SWANN MORTON LTD.; owlerton green; penn works; sheffield, S6 2B J; UK S6 2BJ
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7202545756
• MDR Report Key: 20012290
• Report Number: 9611194-2024-00015
• Device Sequence Number: 14546963
• Product Code: GES
• UDI-Device Identifier: 05033955002053
• UDI-Public: 05033955002053
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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
• Operator of Device: Health Professional
• Device Model Number: NO. 15 CARBON STERILE BLADES
• Device Catalogue Number: 0205
• Device Lot Number: 4842309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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