MAUDE Adverse Event Report: SWANN-MORTON, LTD. SURGICAL SCALPEL BLADE NO.15

Model Number D6205

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 01/07/2020

Event Type  malfunction  

Event Description

The knife blade broke as the disc space was being incised by physician and assistant was holding the nerve root retractor to protect the spinal cord.As it broke, the broken fragment tore the dura.The nerve root and csf were visible.This was repaired with duragen and fibrin glue.Fda safety report id # (b)(4).

• Brand Name: SURGICAL SCALPEL BLADE NO.15
• 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: 10894813
• MDR Text Key: 218980666
• Report Number: 9611194-2020-00001
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D6205
• Device Lot Number: 3302002
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2020
• 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