MINI JOINT DISTRACTOR
Received Apr 18, 2025 · Event occurred Mar 26, 2025
Report 1220246-2025-01554 · MDR key 21865274
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
MINI JOINT DISTRACTORCatalog number
AR-8950JD
Lot number
121230
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR OF THE DEVICE. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO EVIDENCE OF THE FAILURE WAS PROVIDED.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem
ON 04/02/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(6) THAT AN AR-8950JD MINI JOINT DISTRACTOR STOPPED WORKING. THIS OCCURRED IN A CASE ON (B)(6) 2025, WHEN THE RATCHETING MECHANISM ON THE DEVICE STOPPED WORKING. A DIFFERENT DISTRACTOR WAS BROUGHT IN TO COMPLETE THE CASE. NO ADVERSE REACTIONS TO THE PATIENT OCCURRED.