MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY 36KHZ TORQUE WRENCH (SINGLE PACK)

Catalog Number	C7602EA
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A facility reported that a sample cusa clarity 36khz torque wrench (single pack) (c7602ea), contaminated the clean field during brain tumor surgery.They stated that the sales representative brought the sample to the facility by mistake, and the nurse noticed the sticker on the product and replaced the product with a new one.There was no patient injury and no significant surgical delay.
Additional Manufacturer Narrative
The cusa clarity 36khz torque wrench (c7602ea) was not returned for evaluation; therefore, failure analysis is not possible because the unit is not available for evaluation.In addition, no photos showing the reported condition have been provided.Therefore, the complaint is considered unconfirmed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.Additionally, the complaint description states that the sales rep brought the sample product to a hospital by mistake, and it contaminated the clean field during surgery; this reported condition as described is not related to a product defect.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.
Event or Problem Description
N/a.

• Brand Name: CUSA CLARITY 36KHZ TORQUE WRENCH (SINGLE 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: 19624228
• Report Number: 3006697299-2024-00089
• Device Sequence Number: 12346053
• Product Code: LFL
• UDI-Device Identifier: 10381780126317
• UDI-Public: 10381780126317
• 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): 08/10/2024

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: 07/31/2026
• Device Catalogue Number: C7602EA
• Device Lot Number: 7280636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• 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 Age: 71 YR
• Patient Sex: Female