MAUDE Adverse Event Report: APTIS MEDICAL APTIS DRUJ

Model Number	DRUJ-IS160
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
While rehabing his left arm patient felt the device fail on his right arm while pushing up from a chair.
Additional Manufacturer Narrative
Still under investigation the cause of the issue as the device has not be returned yet.Intial findings of the x-ray show device was not implanted correctly.

• Brand Name: APTIS DRUJ
• Common Device Name: APTIS DRUJ
• Manufacturer (Section D): APTIS MEDICAL; 3602 glenview ave; glenview KY 40025
• Manufacturer (Section G): APTIS MEDICAL; 3602 glenview ave; glenview KY 40025
• Manufacturer Contact: bryan babb ; 3602 glenview ave; glenview, KY 40025 ; 5024258584
• MDR Report Key: 23945920
• Report Number: 3004521401-2026-00001
• Device Sequence Number: 15415159
• Product Code: KXE
• UDI-Device Identifier: B013DRUJIS1600
• UDI-Public: B013DRUJIS1600
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K053119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/02/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DRUJ-IS160
• Device Catalogue Number: DRUJ-IS160
• Device Lot Number: 9454906
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2022
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White