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

Model Number	NO. 11P CARBON STERILE BLADES
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following response was sent to the customer, "thank you for bringing your customer complaint to our attention.Reading through the information we have received a carbon sterile sm11p blade has broken during arthroscopic rotator cuff repair.Unfortunately, it does state that no sample blades are available.Without the blade in question or sample blades from the same shelf box or lot number, we are unable to perform the relevant heat treatment hardness tests to ensure this blade has been manufactured to the surgical blade standard bs 2982.We would also check the blade's ductility on our automated load cell.This broken blade must be reported to the relevant competent authorities due to it breaking whilst being used in the above procedure as it falls into the category of an adverse incident.With the use of this lot number by checking through our in-process records, we have been unable to detect any recorded problems that could assist with this complaint, we have also checked our history and to the best of our knowledge, we have received no further customer complaints regarding these blades breaking and we produced and sold (b)(4) carbon sterile sm11p blades on this lot number.We hope you will understand that it is difficult for us to provide you with comments on how this blade came to break due to us not receiving the blade in question or sample blades from the same shelf box or lot number to test, if sample blades were to become available and returned, we would be able to perform the relevant tests and issue you a follow-up 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 how this blade came to break during arthroscopic rotator cuff repair as we have not received the blade in question or any sample blades to investigate.We believe no corrective action is required as we have been unable to establish the root cause due to not receiving the blade in question or sample blades to investigate.We believe no preventive action is required as we have been unable to establish the root cause due to not receiving the blade in question or sample blades to investigate.".
Event or Problem Description
The following description was provided by the healthcare facility, "blade broke".

• Brand Name: SWANN-MORTON NO. 11P CARBON STERILE BLADES
• Common Device Name: SCALPEL BLADE
• Manufacturer (Section D): SWANN MORTON LTD.; owlerton green; penn works; sheffield, S6 2B J; UK S6 2BJ
• Manufacturer (Section G): SWANN MORTON LTD.; owlerton green; penn works; sheffield, S6 2B J; UK S6 2BJ
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7202545756
• MDR Report Key: 20494194
• Report Number: 9611194-2024-00017
• Device Sequence Number: 13345235
• Product Code: GES
• UDI-Device Identifier: 05033955002916
• UDI-Public: 05033955002916
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NO. 11P CARBON STERILE BLADES
• Device Catalogue Number: 0291
• Device Lot Number: 4862309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown