MAUDE Adverse Event Report: TORNIER INC TORNIER HRS MAX IMPACTOR TIP

Catalog Number	ARS10256
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the impactor tip from hrs max broke during final strike with the mallet.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.

• Brand Name: TORNIER HRS MAX IMPACTOR TIP
• 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: 24654733
• Report Number: 0001649390-2026-00294
• Device Sequence Number: 6013069
• Product Code: HWA
• UDI-Device Identifier: 00840338604071
• UDI-Public: 00840338604071
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 03/20/2026

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: ARS10256
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/20/2026
• 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