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

Model Number NO. 11P CARBON STERILE BLADES

Device Problem Fracture (1260)

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

Event Date 11/03/2023

Event Type  malfunction  

Event Description

The following description of the incident was provided by the healthcare facility, "the #11 surgical blade that was used broke apart during incision.When attempting to retrieve the broke piece, the remnants broke again and were successfully removed from the patient." this is already been reported by the healthcare facility and given the reference no.1423395-2023-00075.

Manufacturer Narrative

Please see below the response sent to our customer, "thank you for informing us of this broken blade complaint.Reading the report, a carbon sterile sm11p blade has broken whilst performing a shoulder incision.Unfortunately, the blade in question or sample blades from the same shelf box or lot number are not available for us to test.With this broken blade falling into the category of an adverse incident it has been reported to the relevant competent authorities.It does state that the surgeon went to make the incision deeper, and the blade broke with very little stress doing a shoulder scope.If this blade was in or around the shoulder joint and twisting or lateral pressure was applied this could have caused the blade to break.With us not having the blade in question or sample blades returned, we are unable to check the heat treatment hardness on our calibrated hardness testing lot number, we can inform you that we have received no further customer complaints regarding our carbon sterile sm11p blades breaking of which 48,800 pieces were produced and sold.We hope you will understand that it is difficult for us to comment further due to not having any sample blades returned to test, if any samples were to become available, we would be able to perform the relevant tests and provide you with a further report detailing our findings.If we can be of any further assistance, please do not hesitate to contact us".Please note the date of manufacture was unable to be entered, however as the healthcare facility provided a lot number we were able to identify that the product was manufactured in december 2022 and has an expiry date of 31st december 2027.This event was reported by the distributor under mdr #1423395-2023-00063.

• Brand Name: SWANN-MORTON NO. 11P CARBON STERILE BLADES
• Type of Device: 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: 18282005
• MDR Text Key: 329910296
• Report Number: 9611194-2023-00010
• Device Sequence Number: 1
• Product Code: GES
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO. 11P CARBON STERILE BLADES
• Device Catalogue Number: 0291
• Device Lot Number: 3702303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1