MAUDE Adverse Event Report: TORNIER INC AEQ. RETRACTOR SHOULDER SYSTEM

Catalog Number	9000381
Medical Device Problem Codes	Material Fragmentation (1261); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that items from a primary surgery showed had chunks missing due to prolonged use.These products, which have been in use for 5-7 years, will be returned.
Event or Problem Description
It was reported that items from a primary surgery showed had chunks missing due to prolonged use.These products, which have been in use for 5-7 years, will be returned.
Additional Manufacturer Narrative
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 returned device exhibits signs of degradation and deformation.There is a large visible deep grove as well as a significant gouge near the tip of the device.The device also exhibits discoloration and dark spots.The condition is consistent with wear and multiple uses of the device.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.Based on investigation, the root cause was attributed to a combination of user and wear related issue.The failure was caused due to exposure to high impactful forces and frequent usage.

• Brand Name: AEQ. RETRACTOR SHOULDER SYSTEM
• Common Device Name: RETRACTOR
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21838642
• Report Number: 0001649390-2025-00244
• Device Sequence Number: 7851862
• Product Code: GAD
• UDI-Device Identifier: 00846832021963
• UDI-Public: (01)00846832021963(10)BFA1WXY
• 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): 08/15/2025

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: 9000381
• Device Lot Number: BFA1WXY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2020
• 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