MAUDE Adverse Event Report: TORNIER INC LATITUDE EV; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number	9030375
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not returned at this time.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that during a revision surgery the tip of the driver broke off trying to loosen the ulna cap off of the loose ulna component.No patient complications were reported.

• Brand Name: LATITUDE EV
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• MDR Report Key: 12328279
• Report Number: 3004983210-2021-00064
• Device Sequence Number: 14154806
• Product Code: JDC
• UDI-Device Identifier: 00846832019991
• UDI-Public: 00846832019991
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

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 Catalogue Number: 9030375
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1