MAUDE Adverse Event Report: APTIS MEDICAL APTIS DRUJ; DISTAL RADIO-ULNAR JOINT IMPLANT

Model Number DRUJ-LP20

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

Detailed instructions including visual references are provided to both surgeons and representatives prior to surgery.The section in the technique guide labeled as "radial plate trial positioning" pages 11-13 details proper positioning.Based on the evaluation of the x-ray, these guidelines were not followed.Numerous attempts to obtain patient's weight have been unsuccessful so we have put in 000 pounds in order to submit within the required timeframe.

Event Description

During the initial implantation of the device the plate was placed angulated, approximately 40 degrees from the optimum position described in our technique.The improper position of the plate created an angle with the ulnar stem that was beyond its intended range of motion.The excessive angle allowed the metal of the peg to contact the metal of the distal radial plate.During use this created excessive forces leading to fracture of the distal peg approximately four months after implantation.

• Brand Name: APTIS DRUJ
• Type of Device: DISTAL RADIO-ULNAR JOINT IMPLANT
• Manufacturer (Section D): APTIS MEDICAL; 3602 glenview ave; glenview KY 40025
• Manufacturer Contact: barbara chesher ; 3602 glenview ave; glenview, KY 40025 ; 5024258584
• MDR Report Key: 7267384
• MDR Text Key: 99936917
• Report Number: 3004521401-2018-00001
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/28/2021
• Device Model Number: DRUJ-LP20
• Device Catalogue Number: DRUJ-LP20
• Device Lot Number: K19353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2016
• 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: 54 YR