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U.S. Department of Health and Human Services

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

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SWANN MORTON LTD. SWANN-MORTON NO. 15 CARBON STERILE BLADES; SCALPEL BLADE Back to Search Results
Model Number NO. 15 CARBON STERILE BLADES
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2024
Event Type  malfunction  
Manufacturer Narrative
Please see below response sent to the customer, thank you for informing us of your customer complaint where a carbon sterile sm11p blade has broken during a knee arthroscopy procedure.As you are aware with this blade breaking during a surgical procedure, we are obligated to report this to the relevant competent authorities as it does fall into the category of an adverse incident.Thank you also for trying to obtain as much information as possible as it is vital to this type of complaint, and reading through the report it does state no sample blades are available at this stage for testing.If sample blades were to become available and returned, we would be able to perform the relevant heat treatment hardness tests to ensure the blades had been manufactured to our in-house tolerances and the surgical blade standard bs 2982.We would then be able to issue you with a further report detailing our findings.Using this lot number, we have checked through our in-process records for the manufacturing process of these blades, and we can inform you that we have no problems recorded that could assist us with this complaint, we can also inform you that to the best of our knowledge, we have received no further customer complaints regarding blades breaking and of which we produced and sold (b)(6) carbon sterile sm11p blades on this lot number.We hope you will understand that it is difficult for us to comment further due to not receiving any sample blades for us to test and 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 a knee arthroscopy as the blade in question is not available for testing or sample blades from the same shelf box or lot number.We believe no corrective action is available as we have been unable to establish the root cause due to having no sample blades returned.We believe no preventive action is available as we have been unable to establish the root cause due to having no sample blades returned.
 
Event Description
Please find the following description provided by the healthcare facility, "3 times this week (3 different cases) when using the 15 blades that came in the pack, the blades have broken".It was stated that there was no injury occurred.
 
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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 Key18835302
MDR Text Key337310811
Report Number9611194-2024-00004
Device Sequence Number1
Product Code GES
UDI-Device Identifier05033955002053
UDI-Public05033955002053
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/04/2024
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
Device Operator Health Professional
Device Model NumberNO. 15 CARBON STERILE BLADES
Device Catalogue Number0205
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/26/2024
Initial Date FDA Received03/05/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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