QUICK CONNECT HANDLE, ASSEMBLY

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, AR-9215-1-03, UNIVERSAL QUICK CONNECT HANDLE, SERIAL/BATCH NUMBER (B)(6), WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE TIP OF THE DEVICE WAS BROKEN. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO EXCESSIVE USER-APPLIED MECHANICAL FORCES.

Description of Event or Problem

ON 03/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 QUICK CONNECT HANDLE BROKE DURING USE WITH THE SECONDARY GUIDE DRILLING. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 03/27/2025: THE DEVICE BROKE INSIDE THE PATIENT. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THERE WAS NO CASE DELAY REPORTED. THE BROKEN HANDLE WAS REPLACED USING ANOTHER HANDLE INCLUDED IN THE SET, AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED. THIS OCCURRED DURING AN ANATOMIC TOTAL SHOULDER PROCEDURE ON (B)(6) 2025.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.