PIVOTPOST & CLAMP
Received Jan 15, 2025 · Event occurred Dec 19, 2024
Report 1220246-2025-09463 · MDR key 21157616
Device
Generic name
Operating Room Table Access
Manufacturer
Arthrex, Inc.Model number
PIVOTPOST & CLAMPCatalog number
AR-1560
Lot number
012434
Product problems
- Break
- Break
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
ON 12/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06739377 THAT AN AR-1560 PIVOT POST AND CLAMP HAD THE PIECE THAT MAKES IT SWIVEL BREAK OFF. NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, AR-1560-02 & AR-1560-03. PIVOT POST AND CLAMP, SERIAL/BATCH NUMBER: (B)(6), WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT THE ADJUSTMENT KNOB WAS BROKEN OFF. FUNCTIONAL TESTING OF THE AR-1560-02 WAS NOT CONDUCTED DUE TO THE DAMAGE TO THE ROTATION LEVER. IT WAS NOTED THAT THE PIVOTPOST CLAMP WAS NOT DAMAGED AND FUNCTIONED AS INTENDED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO THE DAMAGE TO THE DEVICE.