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

Catalog Number	C7417S
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the cusa cusa clarity 36khz curved extended sheartip (c7417s) failed the ¿test¿ portion prior to using the cusa.The customer swapped out the tip and the issue corrected itself.The system then received all the necessary checkmarks and passed the ¿test¿.The device was on the sterile field but never passed the "test"; the device was not in contact with the patient beyond that.There was roughly a 30-minute surgical delay until the integra representative went into the or for troubleshooting support.The circulator had to call for additional disposables and the scrub tech had to disassemble/reassemble the handpiece with a new tip.No patient injury occurred.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.C7417s cusa clarity 36khz curved extended sheartip (5 pack) was returned for evaluation: device history record (dhr) review - the dhr was reviewed and and no anomaly was found during the manufacturing and packaging process of this lot that can be associated to the reported condition.Failure analysis - visual evaluation of the returned tip found multiple hairline cracks in the tip, indicative of it being dropped and/or contacting a hard object at some point.This is confirmed to be easily enough damage to cause the tip to fail the test.Root cause - the customer's complaint is confirmed via the evaluation.The root cause is confirmed as damaged tip, causing the tip to fail the test which is likely caused from it being dropped and/or contacting a hard object at some point.The cusa clarity ifu cautions against this.No manufacturing, workmanship, or material deficiency was identified for correction as a result of this complaint investigation.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: 23110500
• Report Number: 3006697299-2025-00113
• Device Sequence Number: 13297555
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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
• Device Lot Number: 7550409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• 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