Elite 12cm Angled Attachment

Description of Event or Problem

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM.EVENTS OCCURRED BETWEEN APRIL 1 ¿ JUNE 30 2026.THIS REPORT SUMMARIZES 87 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. 2 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. 72 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 12 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. 1 EVENT HAD INSUFFICIENT INFORMATION.

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM.REPORTED EVENTS87 EVENTS WERE REPORTED FOR THIS QUARTER.PRODUCT RETURN STATUS72 DEVICES WERE EVALUATED BASED ON HISTORICAL DATA ANALYSIS.1 DEVICE WAS RECEIVED.14 DEVICES HAD INVESTIGATION TYPES THAT HAVE NOT YET BEEN DETERMINED.EVALUATION FINDINGS (RESULTS/COMPONENTS)72 DEVICES: DEGRADATION PROBLEM IDENTIFIED, WEAR PROBLEM, LUBRICATION PROBLEM IDENTIFIED, OVERHEATING PROBLEM IDENTIFIED / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE1 DEVICE: NO DEVICE PROBLEM FOUND / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE14 DEVICES: RESULTS PENDING COMPLETION OF INVESTIGATION / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE.PRODUCT DISPOSITION62 DEVICES: PRODUCT NOT RECEIVED11 DEVICES: SCRAPPED BY STRYKER14 DEVICES: PRODUCT DISPOSITION IS NOT YET DETERMINED.ADDITIONAL INFORMATION87 DEVICES WERE NOT LABELED FOR SINGLE-USE.87 DEVICES WERE NOT REPROCESSED OR REUSED.THIS REPORT WAS IMPACTED BY EMDR SCHEDULED MAINTENANCE OCCURRING JULY 22-27, 2026.