HDS TRACTION BOOT
Received May 29, 2024 · Event occurred Jun 9, 2022
Report 1220246-2024-04198 · MDR key 19415222
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
HDS TRACTION BOOTCatalog number
AR-6529-06
Lot number
10076167
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. ARTHREX IS NOT THE LEGAL MANUFACTURER OF THIS DEVICE, AND THIS COMPLAINT HAS BEEN FORWARDED TO ALLEN MEDICAL FOR EVALUATION, REPORTABILITY ASSES. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE, AND THIS COMPLAINT HAS BEEN FORWARDED TO THE VENDOR FOR EVALUATION, REPORTABILITY ASSESSMENT AND INVESTIGATION THROUGH THE OEM NOTIFICATION PROCESS.
Description of Event or Problem
ON 06/09/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-6529-06 TRACTION BOOT BROKE. THIS OCCURRED DURING AN UNKNOWN CASE WHEN THE BLACK PIECE ON THE EDGE OF THE BOOT BROKE OFF, THERE WAS NO PATIENT EFFECT REPORTED.