MalfunctionHST
3-POINT SHOULDER DISTRACTION SYSTEM
Received Mar 5, 2026 · Event occurred Feb 12, 2026
Report 1220246-2026-01233 · MDR key 24518705
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
3-POINT SHOULDER DISTRACTION SYSTEMCatalog number
AR-1600M
Lot number
15474043
Product problems
- Unintended Movement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 12-FEB-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM WOULD NOT LOCK. WHEN THEY POSITION THE TRACTION TOWER AND TIGHTEN IT INTO PLACE, IT WOULD NOT CATCH, IT DIDN'T TIGHTEN AS IT SHOULD'VE AND THE TENSION LOOSENED. THIS OCCURRED DURING A CASE WITH NO PATIENT AFFECTED.