MAUDE Adverse Event Report: TORNIER INC TORNIER HRS REVERSED TRAY TRIAL 8MM +3.5MM; TEMPLATE

Catalog Number	ARS1023602
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
There is a screw missing in the tray.
Additional Manufacturer Narrative
The reported event could be confirmed based on assessment of available device.Visual inspection of the returned device confirmed that the product has never been used and central screw is indeed missing from the tray a review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.Based on the assessment to root cause is attributed to manufacturing related issue.A non-conformance has been initiated to address the same.If any further information is provided the investigation report will be reassessed.
Event or Problem Description
There is a screw missing in the tray.

• Brand Name: TORNIER HRS REVERSED TRAY TRIAL 8MM +3.5MM
• Common Device Name: TEMPLATE
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24314058
• Report Number: 0001649390-2026-00123
• Device Sequence Number: 4863283
• Product Code: HWT
• UDI-Device Identifier: 00846832094554
• UDI-Public: (01)00846832094554(11)241120(10)AB0506692
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• 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): 05/14/2026

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: Health Professional
• Device Catalogue Number: ARS1023602
• Device Lot Number: AB0506692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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
• Patient Sex: Unknown