3-POINT SHOULDER DISTRACTION SYSTEM
Received Apr 18, 2024 · Event occurred Feb 16, 2021
Report 1220246-2024-02123 · MDR key 19133767
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
3-POINT SHOULDER DISTRACTION SYSTEMCatalog number
AR-1600M
Lot number
10216144
Product problems
- Unintended Movement
- Unintended Movement
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 MAY 5, 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 CONFIRMED THE ALLEGATION. MULTIPLE COMPONENTS ARE DAMAGED. THE CAUSE IS WEAR AND TEAR.
Description of Event or Problem
IT WAS REPORTED BY THE SALES REP THAT DURING CASE PREPARATION, THE AR-1600M, MADE A LOUD SOUND DURING RE-TIGHTEN. THE HANDLE WOULD NO LONGER FULLY TIGHTEN AND WILL ONLY SPIN IN PLACE WITHOUT LOCKING THE ARM FULLY INTO POSITION.