MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OMNI-TRACT®; RETRACTOR

Model Number	11275
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
New integra instruments arrived with rust.These are new instruments in the package currently un-sterile but intended for sterilization.Upon opening the package there was a lot of visible rust present on the instruments.This is the second order of instruments that have arrived in this condition.

• Brand Name: OMNI-TRACT®
• Common Device Name: RETRACTOR
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus road; princeton NJ 08540
• MDR Report Key: 20384439
• Report Number: 20384439
• Device Sequence Number: 12425041
• Product Code: GAD
• UDI-Device Identifier: 10381780271604
• UDI-Public: (01)10381780271604(10)7249180
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2024
• Report Date (Section F): 07/23/2024

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
• Device Model Number: 11275
• Device Catalogue Number: 11275
• Device Lot Number: 7249180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2024
• 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
• Date Report Sent to FDA: 07/23/2024