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

Catalog Number	ARS10245
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	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Driver did not fit down broach handle.
Additional Manufacturer Narrative
Correction: d9 (product returned).The reported event is confirmed based on the available pictures.The device inspection revealed the following.Visual inspection of the returned unit identified no structural defects or deformation, and the observed surface water marks were consistent with normal cleaning and reprocessing residue.However, the item 6 pins (dowel pins) on the handle were found recessed beyond the specified flush condition, preventing proper engagement and obstructing passage of the mating instrument.Per note 5 of the engineering drawing, these pins must remain flush with the corresponding feature on item 5 (axial handle) to ensure correct alignment and functional fit.Furthermore, the incorrect fitment of the dowel pin with the axial handle results in geometric interference preventing the driver from achieving full insertion, thereby rendering the assembly non-functional from a mechanical fit and alignment standpoint.Therefore, the alleged issue is confirmed.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
Driver did not fit down broach handle.

• 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: 23820947
• Report Number: 0001649390-2025-00949
• Device Sequence Number: 9295322
• Product Code: HWA
• UDI-Device Identifier: 00840338603937
• UDI-Public: (01)00840338603937(11)251021(10)EV0225262
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/06/2026

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?: Device Returned to Manufacturer
• 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): Yes
• 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