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 Break (1069)

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

Event Date 04/07/2023

Event Type  malfunction  

Event Description

Please see below the description provided by the healthcare facility, "we had a #11 knife blade break in half during a procedure this morning.The surgeon used the blade to make a 'stab' wound into the knee to insert an arthroscope.Half of the blade broke off inside of the patient's knee.The surgeon was able to retrieve the broken knife blade.".

Manufacturer Narrative

Please see below the response sent to the customer, "thank you for informing us of your customer complaint where a carbon sterile sm11p blade has broken whilst the end-user was making a stab wound into the patient's knee to insert an arthroscope.With this type of complaint, we need the blade in question returned or sample blades from the same shelf box or lot number to test.Without sample blades, we are unable to test the heat treatment hardness to ensure the blade had been manufactured to our in-house tolerance and the surgical blade standard bs 2982 of which we claim compliance.With this blade breaking during the procedure, we must report it to the relevant competent authorities as if falls into the category of an adverse incident.With you providing us with the lot number we have been able to check our in-process records and we have been unable to detect any recorded problems that could aid this complaint.We have also checked our records and we can inform you that we have received no further customer complaints of this nature of which (b)(4) carbon sterile sm11p blades were produced and sold.The only explanation we can offer is with the blade breaking inside the knee, any contact, twisting, or lateral pressure in or around the bone could have caused the blade to break.If the blade in question or any sample blades were to become available, we would be able to perform the relevant tests for our investigation and issue you 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 the root cause of this broken blade due to not having the blade in question or sample blades from the shelf box or lot number to check.The only explanation we can offer is the one mentioned above.We believe no corrective action is required as we have been unable to establish the root cause of the broken blade.We have no problems recorded through our in-process records and we have received no further customer complaints of this nature.No preventive action is required.".

• 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: 16783517
• MDR Text Key: 313712279
• Report Number: 9611194-2023-00001
• Device Sequence Number: 1
• Product Code: GES
• UDI-Device Identifier: 05033955002916
• UDI-Public: 05033955002916
• 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: 04/21/2023

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 Number: NO. 11P CARBON STERILE BLADES
• Device Catalogue Number: 0291
• Device Lot Number: 4152206
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 04/21/2023
• 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