3-POINT SHOULDER DISTRACTION SYSTEM
Received May 21, 2024 · Event occurred Sep 16, 2022
Report 1220246-2024-03610 · MDR key 19361492
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
3-POINT SHOULDER DISTRACTION SYSTEMCatalog number
AR-1600M
Product problems
- Naturally Worn
- Naturally Worn
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 REPORTED EVENT WAS CONFIRMED. THE MANUFACTURER EVALUATION REVEALED THAT THE WHITE, RED AND YELLOW CABLE, THE END CAP (SQUARE) AND THE ROUND TUBE MUST BE RENEWED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR.
Description of Event or Problem
IT WAS REPORTED THAT THE CABLE IS WORN. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.