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

Model Number NO.15 CARBON STERILE BLADES

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

Please see below the response sent to the customer.Thank you for bringing this complaint to our attention.Reading through the report states that a carbon sterile sm15 blade has broken during use on an ankle case.Unfortunately, this is the only information we have received, it states that there are no samples available, and the lot number information is also unavailable.With this broken blade falling into the category of an adverse incident it therefore must be reported to the relevant competent authorities.Without having the lot number information, we are unable to check our in-process records to establish if we have experienced any problems during the production process of these blades and we are also unable to check our history to determine if we have received any further complaints of this nature.Due to us not having the broken blade in question returned or blades from the same shelf box or lot number, we are unable to perform a visual inspection and test the heat treatment hardness to ensure the blade has been manufactured to our in-house tolerances and the surgical blade standard bs2982 of which we claim compliance.We hope you will understand that we are finding it difficult to comment further on this broken blade due to not receiving any sample blades to test and no lot number information.If sample blades and lot number information were to become available and returned, we would be able to investigate thoroughly and issue you with a further report of our findings.If we can be of any further assistance, please do not hesitate to contact us.We have been unable to establish how this blade came to break during use on an ankle case due to us not having any sample blades returned to test and no lot number information to check our records.No corrective action is required as we have been unable to establish the root cause of this broken blade due to having no samples returned to test and no lot number information to check our records.No preventive action is required as we have been unable to establish the root cause of this broken blade due to having no samples returned to test and no lot number information to check our records.This was also submitted to the fda under distributor mdr #1423395-2023-00079.

Event Description

Please see description provided by the healthcare facility."blade breaking during use on an ankle case".

• Brand Name: SWANN-MORTON NO.15 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: 18474136
• MDR Text Key: 332422206
• Report Number: 9611194-2024-00002
• Device Sequence Number: 1
• Product Code: GES
• UDI-Device Identifier: 05033955002053
• UDI-Public: 05033955002053
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO.15 CARBON STERILE BLADES
• Device Catalogue Number: 0205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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