UNIVERS APEX OPTIFIT HUMERAL STEM, 7MM

Description of Event or Problem

ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-9100-07M UNIVERS APEX OPTIFIT HUMERAL STEM (7 MM) EXPERIENCED AN ISSUE DURING IMPLANTATION. AFTER THE STEM WAS IMPLANTED IN THE HUMERUS, THE SURGEON ATTEMPTED TO TIGHTEN THE INFERIOR SCREW USING THE TORQUE-INDICATING HEX DRIVER. DURING TIGHTENING, THE SCREW HEAD REPEATEDLY CAMMED OUT, AND THE DRIVER SLIPPED, PREVENTING FULL TORQUE. THE ISSUE PERSISTED DESPITE CLEARING THE SCREW HEAD OF VISIBLE MATERIAL. THE PROCEDURE WAS COMPLETED WITH THE INITIAL AR-9100-07M UNIVERS APEX OPTIFIT HUMERAL STEM (7 MM) LEFT IMPLANTED. NO PATIENT HARM WAS REPORTED. THE EVENT OCCURRED DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2026: THE INFERIOR SCREW ASSOCIATED WITH THE AR-9100-07M UNIVERS APEX OPTIFIT HUMERAL STEM (7 MM) COULD NOT BE FULLY TIGHTENED DURING IMPLANTATION. AN AR-9224 DRIVER WAS USED; HOWEVER, THE SURGEON REPORTED THAT THE DRIVER APPEARED TO ENGAGE THE SCREW HEAD ONLY PARTIALLY. WHEN TORQUE WAS APPLIED, THE DRIVER SLIPPED BEFORE REACHING THE INDICATED TORQUE LINE. THE SAME AR-9224 DRIVER WAS SUCCESSFULLY USED TO FULLY TIGHTEN THE SUPERIOR SCREW. NO ALTERNATE DRIVER WAS ATTEMPTED. NO DAMAGE WAS OBSERVED TO THE INFERIOR SCREW HEAD OR HEX INTERFACE. THE INFERIOR SCREW WAS LEFT PARTIALLY TIGHTENED AND REMAINED IMPLANTED. NO REPLACEMENT PRODUCTS WERE USED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

Additional Manufacturer Narrative

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