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

Model Number CARBON STERILE SURGICAL BLADE (NO15)

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/03/2021

Event Type  Injury  

Manufacturer Narrative

For final following requests for additional information, the reporter has responded claiming no further information is available. As no further information is currently available, the following report has been sent in response: thank you for informing us of your latest customer complaint where one of our carbon sterile sm15 blades has broken during procedure. The delay in issuing this report has been due to us waiting on further information to be provided. We have now been informed that it is not available. 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. Thank you for providing the two photographs but with evaluation this type of complaint, it would have been beneficial for us to have had the broken blade in question returned or concerning samples from the same shelf box or lot number to investigate. Reading through the complaint report we are also unsure of the procedure this blade was used in. If we were to have had sample blades returned, we would have been able to check the heat treatment hardness to indicate whether the blade had been manufactured to the surgical blade standard bs2982 of which we claim compliance. We could have also checked the ductility on our automated loadcell. Using the lot number you have provided we were able to check our records, where to the best of our knowledge we have received no further customer complaints of this nature. We can also inform you that we produced and sold 582,100 carbon sterile sm15 blades on this lot number. We hope you will understand that it is difficult for us to comment further on how this blade became to break due to the limited information we have received and that we have had no sample blades returned to test. If further information or sample blades were to become available, we would perform a further investigation and issue you with a more detailed report of our findings. If you require any further assistance, please contact us without hesitation.

Event Description

At this time, we only have very limited information which was forwarded on by our us distributor, originating from cardinal healthcare (supply chain). Complaint number (b)(4) created date 06-14-2021 event date (b)(6) 2021 manufacturing site jrz product malfunction/failure mode broken blade product description summary blades breaking in a few packs. They had a blade break off in the patient. They took x-rays and could not find it in the patient. Complaint quantity 1 sample available no presource component# cs00sm15-psprms mfg. Sku number 00sm15 component name blade,#15,carbon steel,surgical,swann-morton,foil,stinvestigated component lot number 4392010 was there an injury yes was there a death no we (swann-morton ltd) sent a request for further information 21/07/2021 and again 09/08/2021).

• 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: 12330189
• Report Number: 9611194-2021-00003
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CARBON STERILE SURGICAL BLADE (NO15)
• Device Catalogue Number: 0205
• Device Lot Number: 4392010
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/21/2021
• 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: Unkown
• Patient Outcome(s): Other