11G CURETTE

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 JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 2 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 2 DEVICES HAD INVESTIGATION TYPES THAT HAVE NOT YET BEEN DETERMINED. EVALUATION FINDINGS (RESULTS/COMPONENTS): 2 DEVICES: RESULTS PENDING COMPLETION OF INVESTIGATION / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION: 1 DEVICE: SCRAPPED BY CUSTOMER. 1 DEVICE: PRODUCT DISPOSITION IS NOT YET DETERMINED. ADDITIONAL INFORMATION: 2 DEVICES WERE LABELED FOR SINGLE-USE. 2 DEVICES WERE NOT REPROCESSED OR REUSED.

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. MFR REPORT # 3015967359-2025-99525. SUPPLEMENTAL RATIONALE. CORRECTED DATA: B5, H6, H11. 2 PREVIOUSLY REPORTED EVENTS WERE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS. 1 DEVICE WAS RECEIVED. 1 DEVICE WAS NOT AVAILABLE FOR EVALUATION. EVALUATION FINDINGS (RESULTS/COMPONENTS). 1 DEVICE: FRACTURE PROBLEM / TIP. 1 DEVICE: NO FINDINGS AVAILABLE / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION 1 DEVICE: SCRAPPED BY STRYKER. 1 DEVICE: PRODUCT NOT RECEIVED.

Description of Event or Problem

NO CHANGE.