SWIVEL LOCK KNOB ASSY
Received Jun 10, 2024 · Event occurred May 24, 2021
Report 1220246-2024-05504 · MDR key 19506227
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
SWIVEL LOCK KNOB ASSYCatalog number
AR-1600A-02
Lot number
UNK
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
H10, H3 - SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, A PHYSICAL EVALUATION OF THE DEVICE WAS NOT PERFORMED. HOWEVER, THE COMPLAINT ALLEGATION IS NOT CONFIRMED WITHOUT THE DEVICE BEING RETURNED OR ANY PHOTOS PROVIDED. THE MOST LIKELY CAUSE OF THIS FAILURE IS ATTRIBUTED TO WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE KNOB WILL NOT STAY LOCKED IN PLACE.