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

Model Number	106-210
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: HEMOSTAT
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; 11 cabot blvd.; mansfield MA 02048
• MDR Report Key: 11693401
• Report Number: 11693401
• Device Sequence Number: 14430685
• Product Code: HRQ
• UDI-Device Identifier: 10381780432876
• UDI-Public: (01)10381780432876
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/18/2021
• Report Date (Section F): 03/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: 106-210
• Device Catalogue Number: 106210
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/18/2021