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

Model Number	NO. 10 CARBON STERILE BLADE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please see below response sent to the customer."reading through the complaint report, when the surgeon made the incision, it was noticed that the tip of the blade was missing.After 30 minutes, the tip of the blade was found in the knee.With this carbon sterile sm10 blade breaking during surgery, 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 for us to investigate, firstly we had to process it through our irradiation facility to ensure it was safe to handle.We then checked the heat treatment hardness on our calibrated hardness testing machine where we achieved a reading of 837hv proving that the blade had been manufactured to our in-house tolerance and the surgical blade standard bs 2982.With the use of the above lot number, we have been able to check our in-process records and we have been unsuccessful in identifying any problems that could be connected to this broken blade.Checking back through our history, we can also inform you that we have received no further customer complaints of this nature of which we produced and sold 569,400 carbon sterile sm10 blades.Considering the results from the heat treatment hardness test indicating that the blade had been manufactured to the surgical blade standard bs 2982, the only explanation we can offer is that you informed us that the tip of the blade was found in the knee, if there was any twisting or excessive lateral pressure in or around the knee, this could have caused the blade to break.Once again thank you for returning the broken blade in question for us to investigate and if we can be of any further assistance, please do not hesitate to contact us".
Event or Problem Description
Please see the description provided by the healthcare facility, "after incision made by surgeon, tip of blade was noticed to be missing.Staff searched for about 30 minutes pa assisting found the missing part of the blade in the knee".

• Brand Name: SWANN-MORTON NO. 10 CARBON STERILE BLADE
• Common Device Name: 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: 17938440
• Report Number: 9611194-2023-00008
• Device Sequence Number: 6671674
• Product Code: GES
• UDI-Device Identifier: 05033955002015
• UDI-Public: 05033955002015
• Combination Product (Y/N): N
• 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): 10/16/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: NO. 10 CARBON STERILE BLADE
• Device Catalogue Number: 0201
• Device Lot Number: 3572303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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