MAUDE Adverse Event Report: TORNIER INC TORNIER HRS ASSEMBLY SCREW 20MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	ARS655102
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery has been performed due to a broken screw on the revive stem.
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, based on the provided x-ray image for investigation.The medical expert opinion revealed the following: based on the single available x-ray image, distal implant breakage can be confirmed; however, further conclusions regarding the condition of the proximal stem, the nature of the suspected separated fragment, and overall implant positioning remain limited due to insufficient radiological views and missing clinical information.While notable osteolysis and possible implant subsidence or low positioning are observed, the root cause of failure cannot be determined without comprehensive clinical details, additional imaging, and the treating physician¿s assessment.Therefore, no definitive conclusion regarding the patient, procedure, or device-related causes of failure can be provided at this time.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
A revision surgery has been performed due to a broken screw on the revive stem.

• Brand Name: TORNIER HRS ASSEMBLY SCREW 20MM
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24888393
• Report Number: 0001649390-2026-00339
• Device Sequence Number: 10564849
• Product Code: HSD
• UDI-Device Identifier: 00846832093267
• UDI-Public: (01)00846832093267(17)240108(21)AZ3418232017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/08/2024
• Device Catalogue Number: ARS655102
• Device Lot Number: AZ3418232017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown