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

Catalog Number	C7415S
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during a surgical procedure for meningioma, when ablating the tumor with c7415s cusa clarity 36khz curved extended microtip¿, the tip of the device snapped.Surgical time was not significantly extended due to product problem.There was the possibility of the product remaining in the patient's body; however, it was confirmed that no broken parts remained in the patient¿s body.Additional information subsequently received as follows: was an x-ray taken to assure no parts left in patient? if not, why not? unknown.What action taken after product problem occurred? (e.G.Replacement)? another product was used to complete the surgery.Patient outcome/status.Unknown if available, please provide us with the patient information.Unknown.
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h11.The c7415s cusa clarity 36khz curved extended microtip¿ plus was not returned and no pictures were provided; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the issue reported by the customer could not be determined.However, the cusa clarity ifu lists the warnings and cautions that could be related to the reported condition: ¿ when the handpiece is powered on, contact of the tip with a hard surface (for example: a metal instrument, tray, staples, clips, instruments, and so on) may damage the tip of the handpiece.¿ to avoid injury or damage to equipment, place system in standby prior to changing tip or clearing a clog.¿ avoid excessive lateral loading of cusa clarity tips.This may result in injury to the patient and/or user, or equipment damage.¿ when testing the handpiece, do not allow the tip to come in contact with any person or object during tip activation.Contact may result in injury to the patient and/or user, or handpiece tip damage.¿to avoid product damage, always use the torque base to hold the handpiece while using the torque wrench to tighten or loosen the tip.Avoid over torqueing the tip.As a result, the root cause is most likely that one or more of the above warnings was not avoided.It was reported that it broke in the patient; however, any of these warnings could apply, since it could have been damaged in any of the aforementioned ways either prior to use in the patient or during use in the patient, then broken off ultimately in the patient.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.
Additional Manufacturer Narrative
Updated fields: d9, e2, g3, g6, h2, h3, h6, h11.The cusa clarity 36khz curved extended microtip¿ plus (c7415s) was returned for evaluation: failure analysis - evaluation of the returned tip confirmed that it was fractured at the distal end.The cusa clarity ifu lists the warnings and cautions that could be related to the reported condition: when the handpiece is powered on, contact of the tip with a hard surface (for example: a metal instrument, tray, staples, clips, instruments, and so on) may damage the tip of the handpiece.To avoid injury or damage to equipment, place system in standby prior to changing tip or clearing a clog.Avoid excessive lateral loading of cusa clarity tips.This may result in injury to the patient and/or user, or equipment damage.When testing the handpiece, do not allow the tip to come in contact with any person or object during tip activation.Contact may result in injury to the patient and/or user, or handpiece tip damage.To avoid product damage, always use the torque base to hold the handpiece while using the torque wrench to tighten or loosen the tip.Avoid over torqueing the tip.Root cause - the root cause is most likely that one or more of the above warnings was not avoided.No manufacturing, workmanship, or material deficiency was identified for correction as a result of this complaint investigation.This will be monitored and trended going forward.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: 22385342
• Report Number: 3006697299-2025-00076
• Device Sequence Number: 8700282
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2025

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
• Device Lot Number: 7446760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 09/12/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/29/2025; 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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