3-POINT SHOULDER DISTRACTION SYSTEM
Received Jan 8, 2026 · Event occurred Dec 19, 2025
Report 1220246-2026-00100 · MDR key 24005314
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
Patient
NA · Unknown
- 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 A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR DUE TO REPEATED USE OF THE DEVICE IN THE FIELD. MANUFACTURING DATE 2015.
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 19-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM ARMS WERE TOO LOOSE AND DROPPED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.