MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE PROXIMAL BODY TRIAL 13DIA; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	ARS742503
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that product was not possible to clean the complete inside of the instrument during the sterilization process.The staff reported that they cut the device into two pieces to check if it was 100% clean.This was done without any confirmation from stryker.During the cleaning process, we are not 100% sure if the staff followed the ifu correctly.
Event or Problem Description
It was reported that product was not possible to clean the complete inside of the instrument during the sterilization process.The staff reported that they cut the device into two pieces to check if it was 100% clean.This was done without any confirmation from stryker.During the cleaning process, we are not 100% sure if the staff followed the ifu correctly.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was partly returned for evaluation.The device inspection revealed: the visual inspection of the returned device shows that the device has been subjected to destructive testing and only one component capture screw has been returned for evaluation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Ifu clearly states that segregate damaged devices and return them to the legal manufacturer to assist with their analysis of the event more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Visual inspection of the returned item indicates that the device underwent destructive testing, and only a single component (capture screw) was provided for evaluation.Consequently, the returned condition is not representative of the device in its intended use or labeled configuration.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: AEQUALIS FLEX REVIVE PROXIMAL BODY TRIAL 13DIA
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 23605196
• Report Number: 0001649390-2025-00840
• Device Sequence Number: 18442609
• Product Code: PHX
• UDI-Device Identifier: 00846832068838
• UDI-Public: 00846832068838
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: Lay User/Patient
• Device Catalogue Number: ARS742503
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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