MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION INTEGRA JARIT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	121132
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While surgeon was working, needle driver broke in the wound.All pieces found and visualized.X-ray called and 2 views taken and there was no foreign body in wound.

• Brand Name: INTEGRA JARIT
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; 1100 campus road; princeton NJ 08540
• MDR Report Key: 15012509
• Report Number: 15012509
• Device Sequence Number: 15141755
• Product Code: MDM
• UDI-Device Identifier: 10381780377139
• UDI-Public: (01)10381780377139
• 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): 07/07/2022
• Report Date (Section F): 07/07/2022

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: 121132
• Device Catalogue Number: 121-132
• Device Lot Number: 100084-1703
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 07/07/2022