MAUDE Adverse Event Report: APTIS MEDICAL APTIS DRUJ

Model Number	DRUJ-IS145
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient claimed he was using a screwdriver to hang a wall mount for a television.He recalls hyper flexing his wrist when he suddenly felt a pop.Per the patient the date the implant failed: about 2 years ago.The doctor who reported the event stated that the patient avoided seeing a hcp due to lack of insurance to cover the cost.Therefore, aptis does not know who much damage could have happened since the event.
Additional Manufacturer Narrative
Still under investigation the cause of the issue as the device has not be returned yet.Per the surgeon's opinion the "plate applied in the face of a distal radius malunion.The radial plate was applied along the ulnar margin of the radius correctly but given the malunion the housing of the radial plate for the ulnar stem was angulated placing significant stresses on the ulnar stem.Failure occurred at the ulnar stem /post junction.".

• 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, LLC; 3602 glenview ave; glenview KY 40025
• Manufacturer Contact: bryan babb ; 3602 glenview ave; glenview, KY 40025 ; 5024258584
• MDR Report Key: 24769045
• Report Number: 3004521401-2026-00002
• Device Sequence Number: 9247945
• Product Code: KXE
• UDI-Device Identifier: B013DRUJIS1450
• UDI-Public: B013DRUJIS1450
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K053119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 03/31/2026

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 Expiration Date: 01/31/2021
• Device Model Number: DRUJ-IS145
• Device Catalogue Number: DRUJ-IS145
• Device Lot Number: K19019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2015
• 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: 31 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Hispanic
• Patient Race: White