PIVOTPOST REPLACEMENT
Received May 30, 2025 · Event occurred May 12, 2025
Report 1220246-2025-02289 · MDR key 22114376
Device
Generic name
Operating Room Table Access
Manufacturer
Arthrex, Inc.Model number
PIVOTPOST REPLACEMENTCatalog number
AR-1560-02
Lot number
012026
Product problems
- Positioning Failure
- Positioning Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem
ON 05/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1560-02 PIVOT POST DOESNT LOCK TIGHTLY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR DUE TO REPEATED USE OF THE DEVICE IN THE FIELD. MANUFACTURING DATE 2020.