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U.S. Department of Health and Human Services

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

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APTIS MEDICAL APTIS DRUJ; DISTAL RADIO-ULNAR JOINT IMPLANT Back to Search Results
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.
 
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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 Key7267384
MDR Text Key99936917
Report Number3004521401-2018-00001
Device Sequence Number1
Product Code KXE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053119
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date06/28/2021
Device Model NumberDRUJ-LP20
Device Catalogue NumberDRUJ-LP20
Device Lot NumberK19353
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/14/2018
Initial Date FDA Received02/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/20/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age54 YR
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