3-POINT SHOULDER DISTRACTION SYSTEM
Received Dec 29, 2025 · Event occurred Dec 5, 2025
Report 1220246-2025-05860 · MDR key 23906911
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
3-POINT SHOULDER DISTRACTION SYSTEMCatalog number
AR-1600M
Lot number
UNK
Product problems
- Positioning Failure
- Positioning Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED. 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 A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO USER ERROR, DUE TO IMPROPER ENGAGEMENT AND/OR OVER-ROTATION OF THE HANDLE, WHICH MAY PREVENT THE THREADS FROM PROPERLY SEATING AND MAINTAINING TIGHTENING FORCE, RESULTING IN THE HANDLE UNSCREWING RATHER THAN TIGHTENING AS INTENDED.
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 16-DEC-2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM HANDLE THAT TURNS CLOCKWISE TO TURN IT DID NOT HOLD IN PLACE. IT UNSCREWED FURTHER BUT WOULD NOT TIGHTEN UP. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.