HDS TRACTION BOOT
Received May 21, 2024 · Event occurred Apr 30, 2022
Report 1220246-2024-03613 · MDR key 19366544
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
HDS TRACTION BOOTCatalog number
AR-6529-06
Product problems
- Unintended Movement
- Unintended Movement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE HIP TRACTION BOOT CLAMP KEPT SLIPPING. THIS WAS NOTED AT THE START OF THE OPERATION BEFORE THE SURGEON SCRUBBED (DURING POSITIONING). THE PLASTIC CLAMP WAS CHANGED TO A NEW ONE. IT SLIPPED AGAIN (DURING POSITIONING) SO THE SURGEON TAPPED IT. THIS STOPPED IT FROM SLIPPING AGAIN. SLIGHT DELAY IN OPERATION DUE TO THIS BUT NO HARM TO PATIENT.
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 COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.