MAUDE Adverse Event Report: INTEGRA YORK PA, INC. INTEGRA® JARIT®; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	121-140
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Tungsten carbide insert came off needle driver.The piece was retrieved without issue and the instrument was sequestered for clinical engineering.The manufacturer has been notified and the device will be returned upon request.No harm came to the patient.Manufacturer response for instrument, manual, surgical, general use, integra® jarit® (per site reporter).Awaiting response.We will return the device for failure analysis if requested.

• Brand Name: INTEGRA® JARIT®
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): INTEGRA YORK PA, INC.; 589 davies dr; york PA 17402
• MDR Report Key: 9659321
• Report Number: 9659321
• Device Sequence Number: 3602873
• Product Code: MDM
• UDI-Device Identifier: 10381780377177
• UDI-Public: (01)10381780377177
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/25/2019
• Report Date (Section F): 10/25/2019

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: 121-140
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 60
• Date Report Sent to FDA: 10/25/2019