MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE PROXIMAL BODY TRIAL 13DIA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	ARS742503
Medical Device Problem Codes	Positioning Failure (1158); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
It was reported that the set screw on the size 13 revive proximal body trial did not properly engage with the distal stem.The cause of the issue is unknown.
Additional Manufacturer Narrative
The reported event was confirmed, since the instrument was returned and matches the alleged failure mode.The device inspection revealed the following: the received device shows significant signs of extensive usage as evident by multiple surface scratches and areas of discoloration.There is no bending to the proximal fins of the device.The fins do show significant scuffs, scratches and discoloration.The central capture pin is still present and appears in one piece.However, the central capture pin is significantly worn down and rounded.Due to the nature of the returned device a functional inspection was not possible since the central pin will not lower and will not engage with any mating parts.Since the returned device is no longer functional a dimensional inspection was not considered necessary.Additionally, during manufacturing, dimensional testing was per-formed and the device was manufactured to specifications.Based on investigation, the root cause was attributed to a combination of wear and abnormal use.The failure was caused by aggressive, frequent usage and several reprocessing cycles 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
It was reported that the set screw on the size 13 revive proximal body trial did not properly engage with the distal stem.The cause of the issue is unknown.

• Brand Name: AEQUALIS FLEX REVIVE PROXIMAL BODY TRIAL 13DIA
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 23233868
• Report Number: 0001649390-2025-00691
• Device Sequence Number: 12947716
• Product Code: KWS
• UDI-Device Identifier: 00846832068838
• UDI-Public: (01)00846832068838(10)CR1318319
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: ARS742503
• Device Lot Number: UNKNOWN
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2019
• 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