MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY 23KHZ STANDARD TIP (5 PACK)

Catalog Number	C7401S
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that when using the cusa clarity 23khz standard tip (c7401s), the doctor noticed that the tip was broken.There was the possibility of the device remaining in the patient¿s body.Another device was used to complete the surgery.No information on surgical delay has been provided.
Additional Manufacturer Narrative
The cusa tip was not returned and available for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.Additionally, no pictures were provided to aid in the investigation.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.The root cause is most likely that one or more of the above warnings was not avoided, in particular most likely one of the warnings about when it is being used during surgery.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
C7401s cusa clarity 23khz standard tip (5 pack) was returned for evaluation: failure analysis - evaluation of the returned tip confirmed that it is fractured completely off at the distal end.However, the fractured off end was also returned, which shows that it was not lost in the patient.Root cause - 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.Therefore, the root cause is most likely that one or more of the above warnings was not avoided, in particular most likely one of the warnings about when it is being used during surgery.No relevant capas were discovered and no other actions have been identified relating to this issue.No manufacturing, workmanship, or material deficiency was identified for correction as a result of this complaint investigation.No further action or investigation planned for this complaint.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 23KHZ STANDARD TIP (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: 21632088
• Report Number: 3006697299-2025-00033
• Device Sequence Number: 18014727
• Product Code: LFL
• UDI-Device Identifier: 10381780466147
• UDI-Public: 10381780466147
• Combination Product (Y/N): N
• PMA/510(K) Number: K182809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: C7401S
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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