MAUDE Adverse Event Report: TORNIER INC LATITUDE FLEXIBLE REAMER 5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	9030394
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
During primary right total elbow replacement, several issues arose regarding latitude ev instrument malfunction.1.During initial preparation of the ulnar, the ulnar jig, right was fitted in place as per the surgical technique.The large sizing humeral spool was slid over the central axel of the jig, and the large bellsaw was then placed over the spool, in preparation for profiling the proximal ulnar.When the surgeon activated the drill-reamer power tool, the bell saw central axel jammed within the hollow central axel of the jig.The surgeon was unable to advance the bellsaw, or remove it, as it appeared that the metal surfaces had jammed together.The jig was fully loosened, the bellsaw detached from the drill / reamer power tool, and the jammed construct was removed, carefully, from the elbow joint.The bellsaw was then able to be detached from the jig.On inspection, the inner hollow tube of the ulnar jig, right, appeared to have metal fatigue, causing the central axel of the bellsaw to jam.The surgeon decided to use the ulnar jig, left, flipped it over, positioned it in place, and completed the profiling of the proximal ulnar, to his satisfaction.No further issues with using the large bellsaw eventuated, so the issue must be with the ulnar jig, right.No injury was apparent to any surrounding tissues.2.During reaming of the ulnar canal (surgeon had sized the prosthesis to be used was a large), which almost straight away was found to be tight / narrow, the 5mm flexible reamer broke.The reamer was removed, inspected and found to be complete.The surgeon was able to complete the surgery without further incident.
Additional Manufacturer Narrative
The reported event could be confirmed based on the image provided by user or third party.The provided image shows that the remaer has little breakage which completely bents the shaft of the reamer near the distal end.The device history record could not be reviewed because the broken part of the affected device was not returned and the lot number was not communicated.Indications of material manufacturing or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Based on investigation the root cause was attributed to a user related issue.The failure was caused due to an application of excessive mechanical force.If device is returned or any further information is provided the investigation report will be reassessed.
Event or Problem Description
During primary right total elbow replacement, several issues arose regarding latitude ev instrument malfunction.1.During initial preparation of the ulnar, the ulnar jig, right was fitted in place as per the surgical technique.The large sizing humeral spool was slid over the central axel of the jig, and the large bellsaw was then placed over the spool, in preparation for profiling the proximal ulnar.When the surgeon activated the drill-reamer power tool, the bell saw central axel jammed within the hollow central axel of the jig.The surgeon was unable to advance the bellsaw, or remove it, as it appeared that the metal surfaces had jammed together.The jig was fully loosened, the bellsaw detached from the drill / reamer power tool, and the jammed construct was removed, carefully, from the elbow joint.The bellsaw was then able to be detached from the jig.On inspection, the inner hollow tube of the ulnar jig, right, appeared to have metal fatigue, causing the central axel of the bellsaw to jam.The surgeon decided to use the ulnar jig, left, flipped it over, positioned it in place, and completed the profiling of the proximal ulnar, to his satisfaction.No further issues with using the large bellsaw eventuated, so the issue must be with the ulnar jig, right.No injury was apparent to any surrounding tissues.2.During reaming of the ulnar canal (surgeon had sized the prosthesis to be used was a large), which almost straight away was found to be tight / narrow, the 5mm flexible reamer broke.The reamer was removed, inspected and found to be complete.The surgeon was able to complete the surgery without further incident.

• Brand Name: LATITUDE FLEXIBLE REAMER 5MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22086760
• Report Number: 0001649390-2025-00369
• Device Sequence Number: 18114310
• Product Code: HWE
• UDI-Device Identifier: 00846832020089
• UDI-Public: 00846832020089
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: 9030394
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 95 KG