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U.S. Department of Health and Human Services

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

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SWANN MORTON LTD. SWANN-MORTON NO. 11P CARBON STERILE BLADE; SCALPEL BLADE Back to Search Results
Model Number NO. 11P CARBON STERILE BLADE
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2024
Event Type  malfunction  
Event Description
Please see response provided from the healthcare facility."no.11p blade broke while performing a shoulder arthroscopy, the patient is fine".
 
Manufacturer Narrative
Please see below the response sent to the customer.Thank you for informing us of your customer complaint.Reading through the complaint report it states that a carbon sterile sm11p blade has broken inside the patient during a shoulder arthroscopy.As you are aware with this blade breaking during use,we are obligated to report this to the relevant competent authorities as it falls into the category of an adverse incident.Unfortunately, it does state that sample blades are not available, without the blade in question or sample blades from the same shelf box or lot number, we are unable to perform the relevant tests for our investigation.We need to test the blade's heat treatment hardness on our calibrated hardness testing machine to ensure the blade has been manufactured to our in-house tolerances and the surgical blade standard bs 2982.If we were to get unbroken blades returned from the same shelf box or lot number, we would also check the ductility of the blade on our automated load cell.With you providing us with a lot number, we have checked our history and to the best of our knowledge, we have received no further customer complaints regarding blades breaking, and of which we produced and sold (b)(4) carbon sterile sm11p blades on this lot number.We have checked our in-process records throughout the production of these blades, and we have no problems recorded that could be linked to this complaint.We hope you will understand that it is difficult for us to comment further due to us not having any sample blades to test.If in the future you were able to return sample blades for us to test, we would be able to perform the relevant tests and issue you another report detailing our findings.If we can be of any further assistance, please do not hesitate to contact us.We have been unable to establish the root cause of this broken blade as we have not received the broken blade in question or sample blades from the same shelf box or lot number for us to test.We believe no corrective action is required as we have been unable to establish the root cause due to us not receiving the blade in question or sample blades to test.We believe no preventive action is required as we have been unable to establish the root cause due to us not receiving the blade in question or sample blades to test.
 
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Brand Name
SWANN-MORTON NO. 11P CARBON STERILE BLADE
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 Key18845538
MDR Text Key337854279
Report Number9611194-2024-00005
Device Sequence Number1
Product Code GES
UDI-Device Identifier05033955002916
UDI-Public05033955002916
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 Health Care Professional
Type of Report Initial
Report Date 03/06/2024
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. 11P CARBON STERILE BLADE
Device Catalogue Number0291
Device Lot Number3802304
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/04/2024
Initial Date FDA Received03/06/2024
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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