MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION INTEGRA JARIT; HEMOSTAT

Model Number 106-210

Device Problem Break (1069)

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

Event Date 02/11/2021

Event Type  malfunction  

Event Description

A kocker broke on the field while surgeon was using.Broken pieces were retrieved and taken off of field and bagged.A flat plate image was taken and a radiologist read to rule out any retained fragments from broken instrument.

• Brand Name: INTEGRA JARIT
• Type of Device: HEMOSTAT
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; 11 cabot blvd.; mansfield MA 02048
• MDR Report Key: 11693401
• MDR Text Key: 246276359
• Report Number: 11693401
• Device Sequence Number: 1
• Product Code: HRQ
• UDI-Device Identifier: 10381780432876
• UDI-Public: (01)10381780432876
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 106-210
• Device Catalogue Number: 106210
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1