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 Type  malfunction  

Manufacturer Narrative

The handle manufacturer to which the blade was attached is not available for inspection and the quality or brand of this handle is unknown and no products were returned for the manufacturer to carry out an investigation. The only information that we have received is a lot number. Images of the broken blades following use were received but we could not identify whether these were related to the lot number in question (3722004). No action can be taken as no samples have been made available. Following manufacturer's requests, no further information has been provided by the customer in order to carry out further investigation. As no samples were received an investigation can only be conducted on production records using the lot numbers provided. The following description has been sent to the customer. Investigation/report: regarding your customer complaint where the end-user claims there have been eight cases of our carbon sterile sm10 blades breaking, some inside patients. We are aware that we received a similar complaint from you in (b)(6) 2020, with the same product and lot number. It states in the complaint report that some of these blades broke inside patients, so as a result, we must report this to the mhra and the fda as this falls into the category of an adverse incident. We are sure you understand that it is very difficult for us to comment on how these blades became to break without receiving the broken blades in question or any samples from the same shelf box or lot number to test. We have received two photographs, one of embossed information on the top of the foil packets and a picture of two blades that appear to be broken in the same place. It would have been beneficial for us to have known the surgical procedure that these blades were used in. Using the lot number, we can inform your that by checking our records, to the best of our knowledge we have received no further customer complaints of this nature, where we produced and sold (b)(4) carbon sterile sm10 blades. We apologize that we are unable to comment further on this complaint due to the lack of information and samples provided. If these were available in the future and returned, we would be able to perform an investigation and issue you with a further report. If we can be of any further assistance, please do not hesitate to contact us. Root cause: the root cause of this complaint could not be determined as we have received very limited information including the surgical procedure that was being performed at the time of breakage and also no samples to perform an investigation on. Could it be possible that the blades could have become fractured or broken whilst they have been fitted or removed from the handle?.

Event Description

The customer's only communicated information was included in a scar document ( (b)(4)) sent to the distributor as follows 'multiple reports of blades breaking, some inside patients. ' swann-morton contacted the distributor further in the attempt to gather more information; however, no further information was provided by the customer. No samples have been returned for investigation purposes and no information regarding the procedures being performed at the time of breakage.

• 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: 11217574
• MDR Text Key: 242400575
• Report Number: 9611194-2021-00001
• Device Sequence Number: 1
• Product Code: GES
• 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

• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CARBON STERILE SURGICAL BLADE
• Device Catalogue Number: 0201
• Device Lot Number: 3722004
• Was Device Available for Evaluation?: No Answer Provided

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/19/2021
• 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: Initial

Patient Treatment Data

Date Received: 01/22/2021 Patient Sequence Number: 1