MAUDE Adverse Event Report: TORNIER INC TORNIER HRS TRIAL PROXIMAL BOD Y, DIA17; TEMPLATE

Catalog Number	ARS1023305
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hrs proximal body spacer screw malfunctioned.The screw was not advancing and just spinning in the proximal body.
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 hrs proximal body spacer screw malfunctioned.The screw was not advancing and just spinning in the proximal body.
Additional Manufacturer Narrative
Correction: h6 health impact code.The reported event was not confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received device appears to be in excellent condition.The device exhibits relatively few marks to the exterior.There are some water marks which confirm the device has been used and undergone cleaning.There is no bending or damage to the proximal fins of the device.Slight deformation to the set screw hex footprint was observed.A functional inspection confirmed the capture pin would not lower as intended to engage with mating parts.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 abnormal use.The failure was caused by aggressive usage which led to the internal spring that controls the capture pin movement lose its compression ability.The weakening of the spring can result in the event noted in this complaint.If more information is provided, the case will be reassessed.

• Brand Name: TORNIER HRS TRIAL PROXIMAL BOD Y, DIA17
• 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: 23727028
• Report Number: 0001649390-2025-00928
• Device Sequence Number: 13422091
• Product Code: HWT
• UDI-Device Identifier: 00846832094516
• UDI-Public: (01)00846832094516(11)240123(10)AZ022157
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/27/2026

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: ARS1023305
• Device Lot Number: AZ2022157
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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