WRIST TRACTION TOWER
Received May 27, 2024 · Event occurred May 11, 2023
Report 1220246-2024-03989 · MDR key 19400607
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
WRIST TRACTION TOWERCatalog number
AR-1611S
Lot number
UNK
Product problems
- Naturally Worn
- Naturally Worn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CABLE OF THE WRIST TRACTION TOWER NEEDS TO BE REPLACED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.
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 OF THE WRIST TRACTION TOWER NEEDS TO BE REPLACED. THE REPORTED EVENT WAS CONFIRMED. THE MANUFACTURER EVALUATION REVEALED THE TOWER IS COMPLETELY DAMAGED AND BEYOND ANY REPAIR. CONSIDERING THE AGE OF THE DEVICE (MFG 2015), THE MOST LIKELY CAUSE IS ATTRIBUTED TO WEAR AND TEAR.