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

Catalog Number	ARS743000
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
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
Sticky revive / hrs handles.Proximal body trial is sticking to the handle after being disengaged.
Event or Problem Description
Sticky revive / hrs handles.Proximal body trial is sticking to the handle after being disengaged.
Additional Manufacturer Narrative
Please refer to h6 (health impact, method, results, & conclusion) codes.The reported event could be confirmed, since., the device was returned and matches the alleged failure mode.The device inspection revealed the following: a visual inspection of the returned device shows there is no notable damage to the body of the instrument or to the spring or foot of the instrument outside of normal.The spring, foot, and lever handle are all appropriately attached and aligned according to manufacturing specifications.A functional inspection of the instrument shows that there is excessive tension and a snapping action of the spring engaging holding the handle and foot securely in place.There is also an inappropriate amount of tension when working against the spring when disengaging the handle.This is a known issue by stryker r&d and has been addressed by an nc which resulted in a future revision change to the design of the handle which is currently in progress.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
Sticky revive / hrs handles.Proximal body trial is sticking to the handle after being disengaged.
Additional Manufacturer Narrative
Correction: conclusion statement.The reported event could be confirmed, since., the device was returned and matches the alleged failure mode.The device inspection revealed the following: a visual inspection of the returned device shows there is no notable damage to the body of the instrument or to the spring or foot of the instrument outside of normal.The spring, foot, and lever handle are all appropriately attached and aligned according to manufacturing specifications.A functional inspection of the instrument shows that there is excessive tension and a snapping action of the spring engaging holding the handle and foot securely in place.There is also an inappropriate amount of tension when working against the spring when disengaging the handle.This is a known issue by stryker r&d and has been addressed by an nc which resulted in a future revision change to the design of the handle which is currently in progress.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material or manufacturing problems were found during the investigation.If more information is provided, the case will be reassessed.

• 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: 22145534
• Report Number: 0001649390-2025-00379
• Device Sequence Number: 7445203
• Product Code: LXH
• UDI-Device Identifier: 00846832068883
• UDI-Public: (01)00846832068883(10)EV0324225A
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 05/05/2026

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: ARS743000
• Device Lot Number: EV0324225A
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 04/27/2026
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 09/30/2025; 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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