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

Catalog Number	C7415S
Medical Device Problem Codes	Crack (1135); Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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
A facility reported that during a surgical procedure, the cusa clarity 36khz curved extended microtip¿ plus (5 pack) (c7415s) broke and the tip was possibly burnt as well.No information on patient injury or surgical delay has been provided; however, additional information has been requested.
Additional Manufacturer Narrative
The cusa clarity 36khz curved extended microtip¿ plus (5 pack) (c7415s) was not returned; therefore, failure analysis is not possible.However, investigation using an image provided by the customer was performed as follows: failure analysis - pictures provided show a fractured tip.However, from the pictures provided, it does not appear "burned", but rather it appears there are incident marks around the area of the fracture, likely from contacting a hard object and leading to the fracture of the tip.However, very limited information has been provided on the alleged incident, product lot information, or anything else, therefore no further failure analysis is possible at this time.Root cause - the complaint is considered confirmed for fractured tip but does not show any evidence of "burned"; therefore, the root cause cannot be determined without device evaluation.Additionally, the cusa clarity ifu contains warnings to heed to prevent tip fractures.No manufacturing, workmanship, or material deficiency was identified for correction because of this complaint investigation, and no other actions have been identified relating to this issue.Therefore, no further action or investigation is planned for this complaint.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.
Event or Problem Description
N/a.

• Brand Name: CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿ PLUS (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: 23513027
• Report Number: 3006697299-2025-00128
• Device Sequence Number: 9770256
• Product Code: LFL
• UDI-Device Identifier: 10381780126379
• UDI-Public: 10381780126379
• 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): 12/22/2025

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: C7415S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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