MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD KNIGHT NASAL SCS 7 400180; INSTRUMENTS - CUTTING & DISSECTING

Catalog Number	400180
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The knight nasal scs 7 (400180) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the returned knight nasal scissors (400180) was received in used condition.Visual evaluation showed that the returned knight nasal scissors (400180) were in used condition, with the handle sheared off.The damage may be the result of rough handling or forcing the blades to cut unintended material.No manufacturing, workmanship, or material deficiency has been identified.Root cause analysis - the reported complaint was confirmed.The returned knight nasal scissors (400180) are in used condition with the handles sheared off.The damage may be the result of rough handling.
Event or Problem Description
A facility reported that during a septoplasty and turbinectomy surgery, while using the product knight nasal scs 7 (400180) for the first time, the scissors snapped in half at the handle.All broken parts were recovered and removed using a grasper.There was a two to three minute delay while retrieving and replacing the broken scissors.There was no patient injury or death, and the patient was under anesthesia when the break occurred.The procedure was successfully completed.

• Brand Name: KNIGHT NASAL SCS 7 400180
• Common Device Name: INSTRUMENTS - CUTTING & DISSECTING
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 24495772
• Report Number: 3014334038-2026-00020
• Device Sequence Number: 14691288
• Product Code: KBD
• UDI-Device Identifier: 10381780158325
• UDI-Public: 10381780158325
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 400180
• Device Lot Number: AA2502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/03/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown