MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION INTEGRA® JARIT®; CUTTER, WIRE

Model Number 275510

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

Event Date 10/10/2023

Event Type  malfunction  

Event Description

Being used for closure post coronary artery bypass graft (cabg) surgery.Working surface of wire cutter that made contact with sternal wire and was visualized flaking off by physician's assistant and the surgeon.

• Brand Name: INTEGRA® JARIT®
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; 11 cabot blvd.; mansfield MA 02048
• MDR Report Key: 18796570
• MDR Text Key: 336424996
• Report Number: 18796570
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 275510
• Device Catalogue Number: 275-510
• Device Lot Number: AA2201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female