3-POINT SHOULDER DISTRACTION SYSTEM
Received Jul 15, 2024 · Event occurred Jun 19, 2024
Report 1220246-2024-06740 · MDR key 19740324
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
3-POINT SHOULDER DISTRACTION SYSTEMCatalog number
AR-1600M
Lot number
14922871
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
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
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-1600M SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR EVALUATION. FUNCTIONAL TESTING WAS NOT PERFORMED AS THE DEVICE WAS DAMAGED. VISUAL INSPECTION NOTED SCRATCHES ALL OVER THE DEVICE, THE CABLE COVER WAS RIPPED OFF, AND SIGNS OF WEAR AND TEAR ALL OVER THE DEVICE WERE NOTED. THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE.