MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY 23KHZ TORQUE WRENCH (SINGLE PACK)

Catalog Number C7601EA

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that an expired cusa clarity 23khz torque wrench (single pack) (c7601ea) was used in an unspecified case.It appears the customer missed the expiry date and left the product on the shelf.No patient injury has been reported.

Event Description

N/a.

Manufacturer Narrative

The cusa clarity 36khz torque wrench (single pack) (c7601ea) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The expiration date is printed on the box label and on the tray barcode label.Based on the dhr review, the expiration date (12/31/2023) printed on the product labels is correct.Therefore, the root cause for this event is related to a use-error due to an oversight by the final user who failed to verify the product¿s expiration date.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 TORQUE WRENCH (SINGLE PACK)
• Type of Device: 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: 18896455
• MDR Text Key: 337579500
• Report Number: 3006697299-2024-00032
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10381780466406
• UDI-Public: 10381780466406
• Combination Product (y/n): N
• PMA/PMN Number: K182809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: C7601EA
• Device Lot Number: 5087393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2024
• Date Device Manufactured: 12/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1