ARM SLEEVE CONNECTOR, S3

Additional Manufacturer Narrative

THE SHOULDER SUSPENSION TOWER IS DESIGNED TO POSITION, SUPPORT AND/OR DISTRACT THE PATIENT¿S SHOULDER IN A VARIETY OF SURGICAL PROCEDURES INCLUDING, BUT NOT LIMITED TO LATERAL ARTHROSCOPIC AND MINI-OPEN SHOULDER SURGERY. THESE DEVICES ARE INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS WITHIN THE OPERATING ROOM SETTING. THE SHOULDER TOWER WAS RECEIVED BY BAXTER. UPON INSPECTION, IT WAS DETERMINED THAT THE CABLE WAS BROKEN AND IT WAS FOUND SEVERAL COSMETIC BLEMISHES. BAXTER SUBMITTED AN ESTIMATE FOR THE REPAIR TO INSURANCE ON BEHALF OF THE PATIENT. CUSTOMER DECLINED THE REPAIR AND REQUESTED THE DEVICE TO BE SCRAPPED. BASED ON THIS INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF A BROKEN CONNECTION BETWEEN UPPER EXTREMITY DISTRACTION WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.

Description of Event or Problem

BAXTER RECEIVED A REPORT STATING THAT THE SHOULD SUSPENSION TOWER AND THE SHOULDER SUSPENSION PULLY SYSTEM BECAME APART. IT WAS DISCOVERED DURING A CASE. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED.