3-POINT SHOULDER DISTRACTION SYSTEM
Received Apr 30, 2024 · Event occurred Oct 5, 2021
Report 1220246-2024-02625 · MDR key 19213579
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
3-POINT SHOULDER DISTRACTION SYSTEMCatalog number
AR-1600M
Lot number
10061590
Product problems
- Defective Device
- Defective Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
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. VENDOR EVALUATION IDENTIFIED SEVERAL DAMAGED COMPONENTS DUE TO WEAR AND TEAR.
Description of Event or Problem
ON (B)(6)2021 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN THE AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM, WILL NOT LOCK IN POSITION. NO PATIENT AFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.