HDS TRACTION BOOT
Received Apr 30, 2024 · Event occurred Sep 14, 2021
Report 1220246-2024-02616 · MDR key 19212952
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
HDS TRACTION BOOTCatalog number
AR-6529-06
Product problems
- Break
- Break
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. COMPLAINT CONFIRMED. THE REPORTED CONDITION WAS DUE TO WEAR AND TEAR OF THE DEVICE. SEE SERVICE EVALUATION.
Description of Event or Problem
ON 09/14/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAN AN AR-6529-06 BOOT IS BROKEN. THIS WAS DISCOVERED DURING USE WITH NO PATIENT IMPACT.