MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE INSERTER-EXTRACTOR HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	ARS743000
Medical Device Problem Codes	Break (1069); Degraded (1153); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The instrument broke during surgery.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction: please refer to h6 device code.The reported event could be confirmed since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following, the device received shows signs of extensive usage evidenced by the appearance of scratches wear marks water marks and severe discoloration.Device also has corrosion marks near the identification engravings or etching.Broken piece of the rod is stuck inside the 20 degree hole of the inserter extractor handle.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation the root cause was attributed to a combination of wear and user related issue.The failure was due to frequent and improper usage.If any further information is provided the complaint report will be updated.
Event or Problem Description
The instrument broke during surgery.

• Brand Name: AEQUALIS FLEX REVIVE INSERTER-EXTRACTOR HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 22863008
• Report Number: 0001649390-2025-00580
• Device Sequence Number: 7650660
• Product Code: LXH
• UDI-Device Identifier: 00846832068883
• UDI-Public: (01)00846832068883(10)CR0218340
• Combination Product (Y/N): N
• 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): 11/21/2025

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: ARS743000
• Device Lot Number: CR0218340
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2019
• 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