Lot unknown (1): the device was not returned and could not be inspected.The field representative reported there to be no damage to the tip of the device.Device history records and complaint history could not be reviewed without either the device or a valid lot number.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A conclusive root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.Device not returned.
|