MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY 36KHZ CURVED EXTENDED SHEARTIP (5 PACK)

Catalog Number	C7417S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the cusa clarity 36khz curved extended sheartip (c7417s) broke during tumor removal.All broken parts were recovered, but there was the possibility of the product remaining in the patient¿s body.Other devices (scissors and bipolar) were used to complete the surgery.There was no patient injury or delay in surgery.Additional information narrative received as follows: there was no problem with how the tip was attached.It was attached by following the guidelines.Since the tumor was comparatively hard, there's a possibility that the strong force was applied when using it.However, no excessive load was applied intentionally.The doctor is not sure though, he assumes that the device was not continuously used for more than 10 minutes.The device was used for around 30 minutes per each tip.The patient is currently stable, and an imaging test showed no signs of remaining product.For what type of procedure was product or device used? external decompression.
Additional Manufacturer Narrative
The cusa clarity 36khz curved extended sheartip (5 pack) (c7417s) is not available for return as per customer; therefore, an evaluation of the device could not be performed.Additionally, lot number was not provided; therefore, the device history record (dhr) could not be reviewed.As a result, the definite root cause cannot be determined.Notwithstanding the foregoing, based on the additional information received, the root cause is most likely accidental excessive loading: the customer reported that the tumor was "comparatively hard" and excessive force was possible.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CUSA CLARITY 36KHZ CURVED EXTENDED SHEARTIP (5 PACK)
• Common Device Name: CUSA CLARITY
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21380295
• Report Number: 3006697299-2025-00018
• Device Sequence Number: 15629574
• Product Code: LFL
• UDI-Device Identifier: 10381780126386
• UDI-Public: 10381780126386
• Combination Product (Y/N): N
• PMA/510(K) Number: K161882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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: C7417S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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