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

Catalog Number	R392
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 9611194-2022-00001
• Device Sequence Number: 5936456
• Product Code: GES
• UDI-Device Identifier: 05033955183929
• UDI-Public: 05033955183929
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: R392
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown