MAUDE Adverse Event Report: SWANN-MORTON, LTD. SWANN-MORTON; SCALPEL BLADE

Model Number	CARBON STERILE SURGICAL BLADE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following response has been sent to the customer, "thank you for informing us of your customer complaint regarding one of our carbon sterile sm10 blades breaking during use.It states in the complaint report that the item is breaking whilst being used on the patient.At this stage, we are unsure of the surgical procedure that the blade was used in, and also we are led to believe that we will not be receiving the blade in question or any further samples from the same lot number or shelf box for us to investigate.With this blade breaking during surgery, it must be reported to the mhra and the fda as it falls into the category of an adverse incident.Checking through our records with the lot number you have provided, we can confirm to the best of our knowledge we have received no further customer complaints of this nature, of which (b)(4) carbon sterile sm10 blades were produced and sold.Due to us not knowing the surgical procedure that this blade was used in, or not having the broken blade in question returned we do find it difficult to comment further on how it became to break during use.If samples of further information were to become available, we would be able to perform a thorough investigation and issue you with a further, more detailed report of our findings.If we can be of any further assistance, please do not hesitate to contact us.".
Event or Problem Description
The only information returned by the customer was "the item is breaking while being used on the patient" and no sample has been returned for review.

• Brand Name: SWANN-MORTON
• Common Device Name: SCALPEL BLADE
• Manufacturer (Section D): SWANN-MORTON, LTD.; owlerton green; sheffield, gb ; UK
• MDR Report Key: 11016154
• Report Number: 9611194-2020-00002
• Device Sequence Number: 13767232
• Product Code: GES
• UDI-Device Identifier: 05033955002015
• UDI-Public: 05033955002015
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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 Expiration Date: 04/30/2025
• Device Model Number: CARBON STERILE SURGICAL BLADE
• Device Catalogue Number: 0201
• Device Lot Number: 3722004
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention