MalfunctionHST
3-POINT SHOULDER DISTRACTION SYSTEM
Received Jun 10, 2026 · Event occurred May 22, 2026
Report 1220246-2026-03329 · MDR key 25457831
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
3-POINT SHOULDER DISTRACTION SYSTEMCatalog number
AR-1600M
Lot number
15412301
Product problems
- Positioning Failure
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 (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM POLE-ADJUSTING KNOB SLIDES AND WOULD NOT REMAIN IN PLACE DURING A CASE. NO PATIENT WAS AFFECTED.