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

Model Number CARBON STERILE SURGICAL BLADE

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2020

Event Type  malfunction  

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 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
• Type of Device: SCALPEL BLADE
• Manufacturer (Section D): SWANN-MORTON, LTD.; owlerton green; sheffield, gb ; UK
• Manufacturer (Section G): SWANN-MORTON, LTD.; owlerton green; sheffield, gb ; UK
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 11016154
• MDR Text Key: 234300862
• Report Number: 9611194-2020-00002
• Device Sequence Number: 1
• Product Code: GES
• UDI-Device Identifier: 05033955002015
• UDI-Public: 05033955002015
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARBON STERILE SURGICAL BLADE
• Device Catalogue Number: 0201
• Device Lot Number: 3722004
• Date Manufacturer Received: 12/15/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention