MAUDE Adverse Event Report: APTIS MEDICAL APTIS DRUJ

Model Number DRUJ-IS160

Device Problem Installation-Related Problem (2965)

Patient Problem Joint Dislocation (2374)

Event Date 04/09/2023

Event Type  Injury  

Manufacturer Narrative

We are still investigating the cause of the issue.The surgeon has indicated he may have implanted the stem incorrectly.But we are waiting for explatation date and decision as to whether the facility will send us the explanted stem for review which was requested on (b)(6) 2023.

Event Description

While at work, the patient was using his hand to lay bricks when he felt his wrist "give out".Ever since then he can dislocate the ulnar stem and reduce it manually.At this point it stays dorsally dislocated unless he keeps it manually reduced or wrapped up tightly.

• Brand Name: APTIS DRUJ
• Type of Device: 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: 17269994
• MDR Text Key: 318561531
• Report Number: 3004521401-2023-00001
• Device Sequence Number: 1
• Product Code: KXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DRUJ-IS160
• Device Catalogue Number: DRUJ-IS160
• Device Lot Number: 9449782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White