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

Model Number	121-260
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Bulldog needledriver: during this process the tip was discovered to be missing a piece.

• Brand Name: INTEGRA JARIT
• Common Device Name: TWISTER, WIRE
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 12438306
• Report Number: 12438306
• Device Sequence Number: 4892322
• Product Code: HXS
• UDI-Device Identifier: 10381780377627
• UDI-Public: (01)10381780377627
• 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): 08/25/2021
• Report Date (Section F): 08/25/2021

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: 121-260
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/25/2021