Model Number 218021 |
Device Problems
Fluid/Blood Leak (1250); Leak/Splash (1354)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/17/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4) investigation summary : despite several attempts to receive additional information regarding the status of the device, none has been made available.Hence, this complaint cannot be confirmed as the complaint device has not been returned, therefore unavailable for evaluation.Based off the information available to mitek customer quality, there is no patient risk or consequences.This complaint file is being closed, should any new information be received in the future, this file will be reopened at that time and updated to reflect the information received.At this time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
|
|
Event Description
|
It was reported by the sales rep via phone that during a shoulder repair procedure the sales rep's inflow/outflow sheath system (stryker) was leaking water around the o-rings.The case was completed with a competitor's device with no patient harm or delay.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Manufacturer Narrative
|
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H6: type of investigation: device history lot: a manufacturing record evaluation was performed for the finished device lot number: 151001, and no nonconformances were identified.Investigation summary: despite several attempts to receive additional information regarding the status of the device, none has been made available.Hence, this complaint cannot be confirmed as the complaint device has not been returned, therefore unavailable for evaluation.A manufacturing record evaluation was performed for the finished device lot number: 151001, and no nonconformances were identified.Based off the information available to mitek customer quality, there is no patient risk or consequences.This complaint file is being closed, should any new information be received in the future, this file will be reopened at that time and updated to reflect the information received.At this time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.
|
|
Search Alerts/Recalls
|
|