(b)(6).
On 08 apr 2019 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.
Writer provided contact information.
Device not yet evaluated, if the device is evaluated a follow up will be sent.
|
Via voicemail: customer stated that they had an issue with one 3 mm kerrison in their possession.
No additional information was provided by the rep at this time.
On 15 apr 2019 additional information: was the product received in this condition? no.
If not, what was the product being used for when it was observed that it had an issue? product was being used on a patient during an ortho-spine procedure.
Please confirm whether or not there was any patient impact.
No harm to the patient has been reported.
Do you have the lot #? unknown.
What exactly is wrong with the product? instrument broke.
The tip of the 3 mm kerrison broke off.
The kerrison will be returned but the tip piece that broke off was lost when it was cleaned after the incident.
Do you have the product number? yes, nl 4252-83t.
No further information available.
On 18 apr 2019 additional information: did any part the instrument fall into the patient's body, and if so how was it retrieved? yes, the tip of the instrument fell into the body and was retrieved with surgical pickups under direct visualization.
Was there a medical procedure performed to verify if the instrument was in the patient's body, such as an x-ray? no, as the instrument tip was directly visualized and removed immediately at time of incident.
What was the patient's outcome? procedure was completed as planned and patient was discharged same day.
Was the procedure completed as planned? yes.
|