3-POINT SHOULDER DISTRACTION SYSTEM
Received Jul 15, 2024 · Event occurred Jun 19, 2024
Report 1220246-2024-06739 · MDR key 19740237
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
3-POINT SHOULDER DISTRACTION SYSTEMCatalog number
AR-1600M
Lot number
10016766
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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 06/19/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS- (B)(4) THAT (2) AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEMS CABLES PLASTIC WAS COMING OFF. THIS WAS DISCOVERED DURING A CASE WITH NO EFFECT ON THE PATIENT.
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 FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR.