MAUDE Adverse Event Report: TORNIER, INC. TORNIER LATITUDE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	9030394
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the surgical procedure, the #5 flexible reamer was broken while utilizing the instrument on patients elbow.Both pieces of reamer obtained.X-ray obtained.Radiologist spoke to attending physician - x-ray negative.

• Brand Name: TORNIER LATITUDE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): TORNIER, INC.; 4375 e. park 30 drive; columbia city IN 46725
• MDR Report Key: 18629335
• Report Number: 18629335
• Device Sequence Number: 18101608
• Product Code: HWE
• UDI-Device Identifier: 00846832020089
• UDI-Public: (01)00846832020089
• 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): 10/17/2023
• Report Date (Section F): 10/17/2023

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: 9030394
• Device Catalogue Number: 9030394
• Device Lot Number: CV0520288
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 10/17/2023