PIVOTPOST REPLACEMENT
Received Jun 18, 2024 · Event occurred Mar 24, 2021
Report 1220246-2024-06047 · MDR key 19564180
Device
Generic name
Operating Room Table Access
Manufacturer
Arthrex, Inc.Model number
PIVOTPOST REPLACEMENTCatalog number
AR-1560-02
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. EVALUATION CONFIRMS COMPONENT C9360-01 (ROTATION LEVER) WAS BROKEN. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.
Description of Event or Problem
IT WAS REPORTED THAT THE BLACK LEVER ON TOP OF THE AR-1560-02 HAS BROKEN OFF.