MICROAIRE ENDOTINE
Received Feb 3, 2023 · Event occurred Jan 11, 2023
Report 2020601-2023-00002 · MDR key 16296481
Device
Generic name
Endotine Forehead, 3.0
Manufacturer
Microaire Surgical Instruments, LlcModel number
CFD-22202Catalog number
CFD-22202
Lot number
368581
Product problems
- Break
- Break
Patient
76 YR · Female
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
AS THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT WAS NOT RETURNED, IT WAS NOT POSSIBLE TO CONDUCT AN EVALUATION OF THE DEVICE. A REVIEW OF THE COMPLAINT HISTORY FOR PART # CFD-22202 LOT # 368581 HAS REVEALED THAT THIS PRODUCT IS PERFORMING AS EXPECTED, WITH REGARD TO THE REPORTED INCIDENT. WITH THE INFORMATION PROVIDED, IT WAS NOT POSSIBLE TO IDENTIFY A ROOT CAUSE; HOWEVER, POTENTIAL USER-RELATED CAUSES OF THE REPORTED INCIDENT INCLUDE, OFF-AXIS DRILLING, EXCESSIVE FORCE DURING IMPLANT INSERTION AND IMPROPER SELECTION OF DEVICE.
Description of Event or Problem
ON JANUARY 17TH 2023, MICROAIRE WAS NOTIFIED BY THE END-USER/DOCTOR FACILITY THAT A PATIENT'S BROW FELL AFTER A BROW LIFT PROCEDURE WAS COMPLETED ON (B)(6) 2022. THE PATIENT WAS SCHEDULED FOR AN EXPLORATION OF THE SURGICAL SITE ON (B)(6) 2023 AND THE DOCTOR IDENTIFIED THAT THE ENDOTINE IMPLANT HAD BROKEN, THERE WAS NO PATIENT INJURY AND THEY WILL NOT BE RETURNING THE BROKEN IMPLAINT TO MICROAIRE FOR EVALUATION.