3-POINT SHOULDER DISTRACTION SYSTEM
Received May 29, 2024 · Event occurred Jul 23, 2021
Report 1220246-2024-04292 · MDR key 19420203
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
3-POINT SHOULDER DISTRACTION SYSTEMCatalog number
AR-1600M
Lot number
12777944
Product problems
- Defective Device
- Defective Device
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON (B)(6)2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING CAUSING DAMAGE TO THE DEVICE DURING SETUP.
Description of Event or Problem
ON (B)(6)2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM IT DOES NOT LOCK.