MAUDE Adverse Event Report: TORNIER INC TORNIER HRS MAX INSERTER AND EXTRACTOR HANDLE; IMPACTOR

Catalog Number	ARS10245
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
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
The long driver (ars742700) would not pass through the broach handle (ars10245) due to a pin on the handle protruding too far, blocking the driver.
Additional Manufacturer Narrative
Correction: d9 (product not returned).The reported event is considered confirmed.Although the product was not returned for evaluation, this was the first eps case, and the field engineer directly observed the malfunction at the time of occurrence.Based on the firsthand technical assessment, the reported assembly impairment is validated.A device inspection was not possible since the affected device was not returned and no other evidence was provided for investigation.A review of the labeling did not indicate any abnormalities.Based on the completed investigation, the root cause is attributed to a manufacturing-related deviation.To ensure thorough evaluation and recurrence prevention, an nc/capa has been initiated for detailed root cause analysis and implementation of corrective and preventive actions.As part of containment, a commercial hold has been applied to the affected batch, and pfa measures have been implemented to control any potential impact until the investigation is fully concluded.If more information is provided, the case will be reassessed.
Event or Problem Description
The long driver (ars742700) would not pass through the broach handle (ars10245) due to a pin on the handle protruding too far, blocking the driver.

• Brand Name: TORNIER HRS MAX INSERTER AND EXTRACTOR HANDLE
• Common Device Name: IMPACTOR
• 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: 23817847
• Report Number: 0001649390-2025-00946
• Device Sequence Number: 9386756
• Product Code: HWA
• UDI-Device Identifier: 00840338603937
• UDI-Public: (01)00840338603937(11)251021(10)EV0225262
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: ARS10245
• Device Lot Number: EV0225262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2025
• 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