WRIST TRACTION TOWER
Received May 21, 2024 · Event occurred Oct 4, 2022
Report 1220246-2024-03609 · MDR key 19361434
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
WRIST TRACTION TOWERCatalog number
AR-1611S
Lot number
14943760
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. EVENT DESCRIPTION: IT WAS REPORTED THAT THE CABLE IS WORN. THE REPORTED EVENT WAS CONFIRMED. THE SUPPLIERS EVALUATION REVEALED DAMAGES ON THE DEVICE WHICH ARE 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.