3-POINT SHOULDER DISTRACTION SYSTEM
Received Aug 12, 2024 · Event occurred Jul 16, 2024
Report 1220246-2024-07139 · MDR key 19961426
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
3-POINT SHOULDER DISTRACTION SYSTEMCatalog number
AR-1600M
Lot number
UNK
Product problems
- Break
- Break
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 FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER-APPLIED EXCESSIVE FORCE DURING THE TIGHTENING PROCESS.
Description of Event or Problem
ON 07/16/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM CABLE WAS DAMAGED. THE CABLE EYE LOOP BROKE AND WAS NOT WORKING AS INTENDED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.