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

Model Number	C7411S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the c7411s cusa clarity 36khz curved extended microtip¿ (5 pack) broke at a position about 3 cm from the tip and fell into the surgical site.All broken parts were removed from the surgical site; however, it is not known how same was removed.They changed to another device, and the procedure was completed.
Additional Manufacturer Narrative
The cusa clarity 36khz curved extended microtip¿ (5 pack) was not returned for evaluation and no pictures were provided; therefore, an evaluation of the device could not be performed.Additionally, the device history record (dhr) could not be reviewed as the lot number has not been provided.The cusa clarity instructions for use (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 the first and/or the third warning was not avoided, since it allegedly broke during the procedure.Based on this evaluation, root cause determination, and risk assessment, no further action or investigation is planned.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.

• 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: 16268145
• Report Number: 3006697299-2023-00006
• Device Sequence Number: 5242101
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2023

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 Model Number: C7411S
• Device Catalogue Number: C7411S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/30/2023
• 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