MAUDE Adverse Event Report: TORNIER INC LATITUDE FLEXIBLE REAMER 6MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY

Catalog Number	9030155
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the latitude ev kit was used.When using 2 of the flexible reamers on the kit they snapped/ broke and therefore will need replacing on the kit.Upon reaming over the guide wire when removing the reamer 1 had snapped in half, the second had snapped but did not come apart.Both reamers were removed successfully including loose items due to the ball tipped wire and nothing was left in the patient.It was reported that, the reamers were finished with so not needed again during surgery.
Additional Manufacturer Narrative
Correction (section h8) from initial use of device to reuse.The reported event could be confirmed, since the device was retuned and matches the alleged failure mode.The device inspection revealed the following.A visual inspection shows a brittle fracture occurring diagonally between two of the flex points engineered into the reamer.The fracture surface shows and abrupt, granular texture which is indicative of a brittle fracture.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a wear related issue.The failure was caused by wear.Device has been in use since 2019 normal weakening of structural integrity can be expected to lead to the event noted in this complaint.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the latitude ev kit was used.When using 2 of the flexible reamers on the kit they snapped/ broke and therefore will need replacing on the kit.Upon reaming over the guide wire when removing the reamer 1 had snapped in half, the second had snapped but did not come apart.Both reamers were removed successfully including loose items due to the ball tipped wire and nothing was left in the patient.It was reported that; the reamers were finished with so not needed again during surgery.

• Brand Name: LATITUDE FLEXIBLE REAMER 6MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork MN NA ; EI NA
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23405626
• Report Number: 0001649390-2025-00771
• Device Sequence Number: 14694155
• Product Code: HWE
• UDI-Device Identifier: 00846832020072
• UDI-Public: (01)00846832020072(11)190610(17)280626(10)CV0119088
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 01/15/2026

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: Lay User/Patient
• Device Catalogue Number: 9030155
• Device Lot Number: CV0119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2019
• 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: Other
• Patient Sex: Unknown