MAUDE Adverse Event Report: TORNIER INC TORNIER HRS REVERSED TRAY, 8MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	ARS1022801
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that during surgery, two hrs -2 polyethylene inserts were unable to seat/lock into the hrs centered tray despite being impacted into place.Both inserts were attempted in vivo and on the back table and did not connect, resulting in their disposal.The centered tray was removed from use, and a new centered tray was opened; however, the original two inserts again failed to seat.After a significant delay, a third insert ¿ a non-vitamin e standard perform +0 poly ¿ was opened and successfully implanted with an eccentric tray.The eccentric tray used for implantation had also failed to seat the original two inserts.
Event or Problem Description
It was reported that during surgery, two hrs -2 polyethylene inserts were unable to seat/lock into the hrs centered tray despite being impacted into place.Both inserts were attempted in vivo and on the back table and did not connect, resulting in their disposal.The centered tray was removed from use, and a new centered tray was opened; however, the original two inserts again failed to seat.After a significant delay, a third insert ¿ a non-vitamin e standard perform +0 poly ¿ was opened and successfully implanted with an eccentric tray.The eccentric tray used for implantation had also failed to seat the original two inserts.
Additional Manufacturer Narrative
The reported event was not confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: a visual inspection of the returned device shows little to know signs of wear or use, aside from minor surface scratches on the top collar of the implant and a slight dent on the stem, both consistent with attempts to assemble the implant during the initial procedure.A dimensional inspection was conducted by the original manufacturing vendor, and all measurements were found to be within specifications.The dimensional inspections conducted during the device¿s initial manufacturing also confirmed that all measurements were within specification.A functional inspection was not deemed necessary, as the device exhibited no notable defects and was confirmed to be within specifications during the dimensional inspection.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.

• Brand Name: TORNIER HRS REVERSED TRAY, 8MM
• 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: 22794807
• Report Number: 0001649390-2025-00564
• Device Sequence Number: 8314745
• Product Code: KWS
• UDI-Device Identifier: 00846832094004
• UDI-Public: 00846832094004
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 12/22/2025

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: ARS1022801
• Device Lot Number: AZ4022351072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown