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

Model Number	C7420S
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that the cusa clarity 23khz bone tip (c7420s) broke during a spinal cord tumor surgery, and it was noted that there was a crack in the flue around the tip.All the broken parts were recovered and it did not result in a health hazard to the patient.Another product was used for the procedure.No information of surgical delay was available.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Cusa clarity 23khz bone tip (c7420s) was returned for evaluation: failure analysis: evaluation of the returned tip confirmed that it was in fact fractured.The angle of the fracture is indicative of excessive lateral loading, which is warned against in the cusa clarity ifu.Root cause: the angle of the fracture is indicative of excessive lateral loading, which is warned against in the cusa clarity ifu, where it states "avoid excessive lateral loading of cusa clarity tips.This may result in injury to the patient and/or user, or equipment damage." based on this evaluation, root cause determination, and risk assessment, no further action or investigation is planned.
Additional Manufacturer Narrative
Cusa clarity 23khz bone tip (5 pack) (c7420s) was not returned 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.The root cause(s) of the reported issue could not be determined.The complaint description states that the flue cracked around the tip during use; therefore, not an out of the box condition.A possible root cause for this could be related to excessive lateral loading of the tip.The following warning can be found in the cusa clarity user guide: avoid excessive lateral loading of cusa clarity tips.This may result in injury to the patient and/or user, or equipment damage.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 23KHZ BONE 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 ; 6099362319
• MDR Report Key: 15562701
• Report Number: 3006697299-2022-00133
• Device Sequence Number: 6576048
• Product Code: LFL
• UDI-Device Identifier: 10381780466178
• UDI-Public: 10381780466178
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2022

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: C7420S
• Device Catalogue Number: C7420S
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 10/12/2022; 11/18/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 10/17/2022; 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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