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

Model Number NO.15 CARBON STERILE BLADE

Device Problem Fracture (1260)

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

Event Date 11/16/2023

Event Type  malfunction  

Event Description

Please see the description provided by the healthcare facility "#15 blade blade broke off while in use and extended surgical time with difficulty in retrieval of the piece broken off in patient wound.Physician stated he utilized minimal action in blade manipulation before the break.The patient had no post-op complications and is doing well".

Manufacturer Narrative

Please see below the response sent to the customer."thank you for informing us of your customer complaint where a carbon sterile sm15 blade broke during surgery.With this blade breaking during a surgical procedure, it falls into the category of an adverse incident and therefore must be reported to the relevant competent authorities.Unfortunately, the blade in question or sample blades from the same shelf box or lot number are not available to be returned for our investigation.We have also received no information on the procedure that was being performed at the time of the breakage and no lot number information for the blade in question.Without having the blade in question returned or sample blades, we are unable to check the heat treatment hardness to determine whether the blade had been manufactured to the surgical blade standard bs 2982 of which we claim compliance.Without the lot number, we are unable to check our in-process records for any problems and our history to see if we have received any further customer complaints of this nature.We hope you will understand that it is difficult for us to comment further on how this blade came to break due to us receiving limited information and no sample blades to test.If the relevant information and sample blades were to become available and returned, we would be able to perform a thorough investigation 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." this was also submitted to the fda under distributor mdr #1423395-2023-00077.

• Brand Name: SWANN-MORTON NO.15 CARBON STERILE BLADE
• Type of Device: SCAPEL 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: 18474147
• MDR Text Key: 332422271
• Report Number: 9611194-2024-00001
• 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
• 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 BLADE
• Device Catalogue Number: 0205
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2023
• 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