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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Please see the description provided by the healthcare facility."the surgeon went to make the incision deeper, and the blade broke with very little stress on it doing a shoulder scope".It was reported the event occurred about 45 minutes into the procedure.It was reported that "we looked for it with the scope and removed the broken end with a needle holder.The pieces were all account for with no injury to staff or patient.".
Additional Manufacturer Narrative
Please see below the response sent to our customer, "thank you for informing us of this broken blade complaint.Reading the report, a carbon sterile sm11p blade has broken whilst performing a shoulder incision.Unfortunately, the blade in question or sample blades from the same shelf box or lot number are not available for us to test.With this broken blade falling into the category of an adverse incident it has been reported to the relevant competent authorities.It does state that the surgeon went to make the incision deeper, and the blade broke with very little stress doing a shoulder scope.If this blade was in or around the shoulder joint and twisting or lateral pressure was applied this could have caused the blade to break.With us not having the blade in question or sample blades returned, we are unable to check the heat treatment hardness on our calibrated hardness testing machine to ensure the blade had been manufactured to the surgical standard bs 2982 of which we claim compliance.Using this lot number, we can inform you that we have received no further customer complaints regarding our carbon sterile sm11p blades breaking of which (b)(4) pieces were produced and sold.We hope you will understand that it is difficult for us to comment further due to not having any sample blades returned to test, if any samples were to become available, we would be able to perform the relevant tests and provide you with a further report detailing our findings.If we can be of any further assistance, please do not hesitate to contact us".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 december 2022 and has an expiry date of 31st december 2027.This event was reported by the distributor under mdr #1423395-2023-00063.
Additional Manufacturer Narrative
The original mdr 9611194-2023-00009, submitted on 03-nov-2023 was missing the following blocks: b4 - date of report d4 - udi block b4 should have contained the date 03-nov-2023 and block d4 should have contained the uda #(b)(4).

• Brand Name: SWANN- MORTON NO.11P CARBON STERILE BLADES
• Common Device Name: 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: 18064066
• Report Number: 9611194-2023-00009
• Device Sequence Number: 7317783
• Product Code: GES
• UDI-Device Identifier: 05033955002916
• UDI-Public: 05033955002916
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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
• Operator of Device: Health Professional
• Device Model Number: NO.11P CARBON STERILE BLADES
• Device Catalogue Number: 0291
• Device Lot Number: 5472212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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