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 Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following response was sent to the customer: "thank you for bringing your customer complaint to the attention of our sales department.Reading through the report it states that a carbon sterile sm11p blade has broken during a knee arthroscopy.Unfortunately, there is no further information, the blade in question or sample blade from the same lot number for us to investigate.If we would have had sample blades returned, we would be able to check the heat treatment hardness on our calibrated hardness testing machine to ensure this blade had been manufactured to our in-house tolerance and the surgical blade standard bs 2982.With this blade breaking during a surgical procedure, it falls into the category of an adverse incident and as such this has been reported to the relevant competent authorities.Using the above lot number and our in-process records, we have checked for any recorded problems that could be linked to this broken blade, none could be found.By checking our history, we can also inform you that to the best of our knowledge we have received no further complaints of this nature of which (b)(4) carbon sterile sm11p blades were produced and sold on this lot number.We are finding it difficult to comment further as no sample blades are available for us to test, if samples were to become available, we would be able to perform the relevant tests and issue you with a further report detailing our findings.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 due to us not having the broken blade in question or sample blades from the same lot number for us to test.We believe no corrective action is required as we have been unable to establish the root cause due to us not receiving sample blades to test.We believe no preventive action is required as we have been unable to establish the root cause due to us not receiving sample blades to test." this was also reported under mdr #: 1423395-2024-00425.
Event or Problem Description
The following description was provided by the healthcare facility, "blade broke during knee arthroscopy".It was also stated that, "no injury to the patient reported" and the "surgeon had to use the camera and additional instrumentation to locate the tip of the blade".

• 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: 19548500
• Report Number: 9611194-2024-00012
• Device Sequence Number: 4734012
• Product Code: GES
• UDI-Device Identifier: 05033955002916
• UDI-Public: 05033955002916
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/17/2024

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: 4242306
• 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: 06/14/2024
• Initial Report FDA Received Date: 06/17/2024
• 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