Model Number 72202468 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
It was reported that during a meniscus repair, t2 of the fast-fix could not be triggered because the trigger slider could not be pushed back after t1 was triggered.The procedure was completed with a s+n back up device.There was a non-significant surgical delay and no further complications were reported.
|
|
Manufacturer Narrative
|
H10: internal complaint reference : (b)(4).
|
|
Event Description
|
It was reported that during a meniscus repair, t2 of the fast-fix could not be triggered because the trigger slider could not be pushed back after t1 was triggered.T1 was removed from the patient.The procedure was completed with a s+n back up device.There was a non-significant surgical delay and no further complications were reported.
|
|
Manufacturer Narrative
|
A device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
|
|
Manufacturer Narrative
|
H10: internal complaint reference: (b)(4).B5 and h6 updated.
|
|
Event Description
|
It was reported that during a meniscus repair, t2 of the fast-fix could not be triggered because the trigger slider could not be pushed back after t1 was triggered.T1 was removed form the patient.The procedure was completed with a s+n back up device.There was a non-significant surgical delay and no further complications were reported.
|
|
Search Alerts/Recalls
|