MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE PROXIMAL BODY TRIAL 9DIA; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	ARS742501
Medical Device Problem Codes	Break (1069); Fracture (1260)
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.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that while impacting the trial assembly into the humerus, the proximal body detached from the stem due to broken retaining tabs.The stem trial remained in the humeral canal and was removed using needle nose pliers.All debris was confirmed removed via x-ray.The case was delayed approximately 40 minutes.
Additional Manufacturer Narrative
Correction: h6 health impact code.The reported event was confirmed since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following the received device shows signs of extensive usage as evident by wear marks scratches water marks or discoloration on the entire surface and corrosion marks near the identification engravings and at other places.The trail has clear breakage at the distal end broken fragments were not returned for inspection.The breakage pattern indicates it to be a ductile fracture.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 user and wear related issue.The failure was caused by improper handling and frequent usage.If any further information is provided the complaint report will be updated.
Event or Problem Description
It was reported that while impacting the trial assembly into the humerus, the proximal body detached from the stem due to broken retaining tabs.The stem trial remained in the humeral canal and was removed using needle nose pliers.All debris was confirmed removed via x-ray.The case was delayed approximately 40 minutes.

• Brand Name: AEQUALIS FLEX REVIVE PROXIMAL BODY TRIAL 9DIA
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 21877653
• Report Number: 0001649390-2025-00260
• Device Sequence Number: 8741940
• Product Code: HSD
• UDI-Device Identifier: 00846832068814
• UDI-Public: (01)00846832068814(10)AZ1319275
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: ARS742501
• Device Lot Number: AZ1319275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2020
• 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