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

Catalog Number	C7411S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during use, the tip of the cusa clarity 36khz curved extended microtip (c7411s) broke.There was a possibility that part of the product remained in the patient¿s body; therefore, a ct scan was performed which confirmed the absence of any remaining product in the patient¿s body.The same device was utilized to finalize the surgery.No information was provided on the surgical delay.
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
Cusa clarity 36khz curved extended microtip¿ (5 pack) ) (c7411s) was returned for evaluation: device history record (dhr) - the device history record (dhr) was reviewed and no anomalies were found which could contribute and/or be related to the reported condition.Failure analysis - investigation of the returned tip confirmed that it is in fact 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 torquing the tip.Root cause - the complaint is confirmed.The root cause is undetermined and most likely that one or more of the warnings in the instructions for use (ifu) was not avoided.No manufacturing, workmanship, or material deficiency was identified for correction as a result of this complaint investigation.Therefore, no further action or investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿ (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 ; 6099362319
• MDR Report Key: 18628398
• Report Number: 3006697299-2024-00015
• Device Sequence Number: 7981951
• Product Code: LFL
• UDI-Device Identifier: 10381780126355
• UDI-Public: 10381780126355
• 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,Followup
• Report Date (Section B): 03/01/2024

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 Expiration Date: 06/30/2026
• Device Catalogue Number: C7411S
• Device Lot Number: 7254502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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