MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM FX IMPACTOR HANDLE

Catalog Number	IFX818
Medical Device Problem Codes	Corroded (1131); Material Discolored (1170); Residue After Decontamination (2325); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
A facility reported to us that our consignment ifx818 had been sterilized with bio burden, and they are now unable to fully clean the cannulated instrument.

• Brand Name: TORNIER PERFORM FX IMPACTOR 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 ; +1(201)831-5000
• MDR Report Key: 25106905
• Report Number: 0001649390-2026-00406
• Device Sequence Number: 16139747
• Product Code: HWA
• UDI-Device Identifier: 00846832086955
• UDI-Public: (01)00846832086955(11)221115(10)22A938
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: IFX818
• Device Lot Number: 22A938
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/19/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown