MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE TRIAL SPACER 9DIA 30MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	ARS742402
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a piece broke off on double sided end.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the alleged failure mode.The device inspection revealed the following: inspection of the returned device revealed significant signs of wear.A tab located at the bottom of the instrument is broken off and missing, consistent with a brittle fracture.The body of the instrument exhibits widespread discoloration, and both the cap and central rod shows extensive wear, including visible gouging and pitting on the metal surfaces.Due to the nature of the returned device a functional inspection and dimensional inspection was not considered necessary nor possible was the device is clearly damaged rendering it non-functional.However, during manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications based on investigation, the root cause was attributed to a combination of user and wear related issues.The event was caused by several reprocessing cycles weakening the material of the device in combination with excessive torsional forces being applies to the instrument during use.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 a piece broke off on double sided end.

• Brand Name: AEQUALIS FLEX REVIVE TRIAL SPACER 9DIA 30MM
• 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: 21740692
• Report Number: 0001649390-2025-00189
• Device Sequence Number: 8789900
• Product Code: HSD
• UDI-Device Identifier: 00846832068746
• UDI-Public: (01)00846832068746(10)CR0813819
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• 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): 06/27/2025

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: Lay User/Patient
• Device Catalogue Number: ARS742402
• Device Lot Number: CR0818319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2019
• 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