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

Model Number NO. 11P CARBON STERILE BLADE

Device Problem Insufficient Information (3190)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

Please see the description provided by the healthcare facility, "the surgeon was making an incision to complete tear in shoulder" when the "11p blade broke in half while inside the patient".The customer reported that the blade was "retrieved with a grasper" and that "no serious injury occurred and no follow-up was needed".The customer reported that the "patient is fine".

Manufacturer Narrative

Regarding your customer complaint where a carbon sterile sm11p blade broke in half during an orthopedic shoulder procedure.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.As stated in the previous complaint that we received on14th march 2024, with this being the second complaint describing the same blade, same procedure, same date, lot number, and health care facility, is it possible this is the same complaint that has been reported twice? reading the report, we can see that the blade in question or sample blades from the same shelf box or lot number are not available to be returned to help us in our investigation.Without having sample blades to test, we are unable to check the heat treatment hardness to ensure the blades had been manufactured to our in-house tolerances and the surgical blade standard bs 2982.If the blade in question or sample blades were to become available and you could return them, we could then perform the relevant tests mentioned above, we would then be able to issue you with another report detailing our findings.With you providing us with this lot number, we have checked our in-process records and we have no problems recorded that could assist us with this broken blade, we can also inform you that apart from your previous complaint, we have not received any further customer complaints regarding blades breaking and we produced and sold 85,600 carbon sterile sm11p blades on this lot number.Thank you for informing us of your customer complaint 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 broke during an orthopedic shoulder procedure due to not having the blade in question or sample blades from the same shelf box or lot number returned for us to test.No corrective action is required as we have been unable to establish the root cause due to not having any sample blades returned to test.No preventive action is required as we have been unable to establish the root cause due to not having any sample blades returned to test.Please note the date of manufacture was unable to be entered, however as the healthcare facility provided a lot number we were able to identify that the product was manufactured in august 2023 and there has an expiry date of 31st august 2028.Incident reported to fda as mdr-30.Reference no.1423395-2024-00117.

• 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 Key: 18940168
• MDR Text Key: 338125386
• Report Number: 9611194-2024-00007
• 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
• Type of Report: Initial
• Report Date: 03/20/2024

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 Number: NO. 11P CARBON STERILE BLADE
• Device Catalogue Number: 0291
• Device Lot Number: 4612308
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2023
• 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