3-POINT SHOULDER DISTRACTION SYSTEM
Received May 30, 2024 · Event occurred May 5, 2022
Report 1220246-2024-04368 · MDR key 19424571
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
3-POINT SHOULDER DISTRACTION SYSTEMCatalog number
AR-1600M
Product problems
- Fitting Problem
- Fitting Problem
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 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. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER-APPLIED EXCESSIVE MECHANICAL FORCES.
Description of Event or Problem
ON 05/05/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM WAS NOT LOCKING, NOT GETTING TIGHT. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.