MAUDE Adverse Event Report: SWANN MORTON LTD. ASR BULK NO. 15T BLADE; SCALPEL BLADE

Catalog Number R392

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

The customer reported that during the surgical procedure, the blade from the scalpel broke in half inside the patient's knee.A larger incision needed to be made to remove the broken piece.The broken blade was removed in one piece and per protocol, an xray was taken to verify there was no product left behind.There was no harm to the patient or staff due to this broken scalpel blade.

• Brand Name: ASR BULK NO. 15T BLADE
• Type of Device: 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: 13319091
• MDR Text Key: 287207394
• Report Number: 9611194-2022-00001
• Device Sequence Number: 1
• Product Code: GES
• UDI-Device Identifier: 05033955183929
• UDI-Public: 05033955183929
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: R392
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention