MICROAIRE ULTRATINE
Received Feb 11, 2022 · Event occurred Jan 12, 2022
Report 2020601-2022-00001 · MDR key 13514745
Device
Generic name
Ultratine Forehead 3.0
Manufacturer
Microaire Surgical Instruments, LlcModel number
CFD-23202Catalog number
CFD-23202
Lot number
360045
Product problems
- Deformation Due to Compressive Stress
- Deformation Due to Compressive Stress
Patient
Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER STATED THAT ONE (1) OF THE ULTRATINE (CFD-23202 LOT # 360045) BROKE UPON INSERTION. THEY WERE ABLE TO USE A REPLACEMENT (CFD-23202 LOT # 348147) TO SUCCESSFULLY COMPLETE THE SURGERY. DUE TO THE INITIAL IMPLANT BREAKING THIS CAUSED A ONE (1) HOUR DELAY
Additional Manufacturer Narrative
A REVIEW OF THE DEVICE HISTORY RECORD ASSOCIATED WITH CFD-23202 LOT # 360045 DID NOT IDENTIFY ANY ANOMALIES WITHIN THE MANUFACTURING PROCESS WHICH WOULD CONTRIBUTE TO THIS TYPE OF FAILURE. THIS DEVICE WAS MANUFACTURED ON 05-13-2021, PLACED INTO FINISHED GOODS ON 06-21-2021 WITH AN ORIGINAL SHIP DATE OF 06-21-2021 TO THE CUSTOMER. MICROAIRE RECEIVED THE COMPLAINT PRODUCT ON 01-21-2022 AND WITHIN THE COMPLAINT INCIDENT REPORT (CIR) THE CUSTOMER INDICATED THAT THE SURGERY WAS DELAYED/EXTENDED BY 1 HOUR. VISUAL EVALUATION OF THE PRODUCT IDENTIFIED A BREAK AT THE PLATFORM/POST INTERFACE. THE COMPRESSION FLANGES ARE STILL INTACT ON THE POST WHICH CONFIRMS THAT THE DEVICE BROKE PRIOR TO FULL INSERTION WITHIN THE SURGICAL SITE. EXCESSIVE LOADING/FLEXURE ON THE PLATFORM CAN CREATE A BENDING MOMENT THAT RESULTS IN FRACTURES/BREAKAGE IN THE PLATFORM OF THE DEVICE. THIS CAN BE A RESULT OF INTERACTION WITH TISSUE OR OTHER SURFACES.
Additional Manufacturer Narrative
A REVIEW OF THE DEVICE HISTORY RECORD ASSOCIATED WITH CFD-23202 LOT # 360045 DID NOT IDENTIFY ANY ANOMALIES WITHIN THE MANUFACTURING PROCESS WHICH WOULD CONTRIBUTE TO THIS TYPE OF FAILURE. THIS DEVICE WAS MANUFACTURED ON 05-13-2021, PLACED INTO FINISHED GOODS ON 06-21-2021 WITH AN ORIGINAL SHIP DATE OF 06-21-2021 TO THE CUSTOMER. MICROAIRE RECEIVED THE COMPLAINT PRODUCT ON 01-21-2022 AND WITHIN THE COMPLAINT INCIDENT REPORT (CIR) THE CUSTOMER INDICATED THAT THE SURGERY WAS DELAYED/EXTENDED BY 1 HOUR. VISUAL EVALUATION OF THE PRODUCT IDENTIFIED A BREAK AT THE PLATFORM/POST INTERFACE. THE COMPRESSION FLANGES ARE STILL INTACT ON THE POST WHICH CONFIRMS THAT THE DEVICE BROKE PRIOR TO FULL INSERTION WITHIN THE SURGICAL SITE. EXCESSIVE LOADING/FLEXURE ON THE PLATFORM CAN CREATE A BENDING MOMENT THAT RESULTS IN FRACTURES/BREAKAGE IN THE PLATFORM OF THE DEVICE. THIS CAN BE A RESULT OF INTERACTION WITH TISSUE OR OTHER SURFACES.
Description of Event or Problem
THE CUSTOMER STATED THAT ONE (1) OF THE ULTRATINE (CFD-23202 LOT # 360045) BROKE UPON INSERTION. THEY WERE ABLE TO USE A REPLACEMENT (CFD-23202 LOT # 348147) TO SUCCESSFULLY COMPLETE THE SURGERY. DUE TO THE INITIAL IMPLANT BREAKING THIS CAUSED A ONE (1) HOUR DELAY