MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION INTEGRA® JARIT®; INSTRUMENT, SURGICAL, NON-POWERED

Model Number	285120
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Gerald forceps tip missing from one side.

• Brand Name: INTEGRA® JARIT®
• Common Device Name: INSTRUMENT, SURGICAL, NON-POWERED
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; 11 cabot blvd; mansfield MA 02048
• MDR Report Key: 18586575
• Report Number: 18586575
• Device Sequence Number: 7049970
• Product Code: HAO
• UDI-Device Identifier: 10381780024965
• UDI-Public: (01)10381780024965(10)925789
• 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): 10/11/2023
• Report Date (Section F): 10/11/2023

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
• Device Model Number: 285120
• Device Catalogue Number: 285-120
• Device Lot Number: 925789
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2024
• 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: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 10/11/2023