PIVOTPOST REPLACEMENT
Received Jun 10, 2024 · Event occurred May 9, 2023
Report 1220246-2024-05464 · MDR key 19503288
Device
Generic name
Operating Room Table Access
Manufacturer
Arthrex, Inc.Model number
PIVOTPOST REPLACEMENTCatalog number
AR-1560-02
Lot number
021506
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. 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. MANF. 2014.
Description of Event or Problem
ON 05/09/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1560-02 PIVOT POST ROTATOR IS BROKEN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT EFFECT.