MAUDE Adverse Event Report: TORNIER INC TORNIER HRS TRIAL PROXIMAL BOD Y, DIA11; TEMPLATE

Catalog Number	ARS1023302
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
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 ars743000 would get stuck on the proximal body trials after every impaction.According to the stryker rep, this made the trialling very difficult (need a way to loosen how tight the handle mates onto the proximal body trials).Additional information from the stryker rep may 21: "i tried the handle on one of our ltc proximal bodies and vice-versa, and it turns out that the handle is not the problem at all, it worked perfectly.The problem is with the new proximal body trials (ars1023301-ars1023306).They were sticky on the old handle as well".

• Brand Name: TORNIER HRS TRIAL PROXIMAL BOD Y, DIA11
• 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: 25521989
• Report Number: 0001649390-2026-00566
• Device Sequence Number: 10627545
• Product Code: HWT
• UDI-Device Identifier: 00846832094486
• UDI-Public: 00846832094486
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/16/2026

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: ARS1023302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/16/2026
• 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
• Patient Sex: Unknown