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

Model Number	NO. 11P CARBON STERILE BLADES
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following response was sent to the customer, "thank you for bringing this customer complaint to our attention.Reading through the description summary it is very similar to your previous two complaints (b)(4), we are also unsure whether this blade has broken whilst fitting it to a handle or during surgery.Due to it stating that blades are breaking in preparation for and during surgeries, we feel this needs to be reported to the relevant competent authorities as it falls into the category of an adverse incident.With us not having the blade in question or sample blades from the same shelf box or lot number returned, we are unable to test the heat treatment hardness on our calibrated testing machine to ensure the blade had been manufactured to the surgical blade standard bs 2982.With you providing us with the lot number, we can inform you that apart from your previous complaint (b)(4)., we have received no further complaints regarding blades breaking of which (b)(6) carbon sterile sm15 blades were produced and sold on this lot number.We have also been unable to detect any recorded problems through our in-process records that could be linked to this complaint.We hope that you will understand that we are finding it difficult to provide you with any further comments due to the lack of information provided and having no sample blades to test.If sample blades and further information were to become available and returned, we would be able to provide 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 has broken due to us receiving very limited information and not having any sample blades returned for us to test.We believe no corrective action is required as we have been unable to establish the root cause due to us receiving very limited information and not having any sample blades returned for us to test.We believe no preventive action is required as we have been unable to establish the root cause due to us receiving very limited information and not having any sample blades returned for us to test.".
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".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.

• Brand Name: SWANN-MORTON NO. 11P 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: 20007285
• Report Number: 9611194-2024-00014
• Device Sequence Number: 13722509
• Product Code: GES
• UDI-Device Identifier: 05033955002916
• UDI-Public: 05033955002916
• 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. 11P CARBON STERILE BLADES
• Device Catalogue Number: 0291
• Device Lot Number: 5292312
• 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: 08/20/2024
• 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