|
Model Number 7209485 |
Device Problem
Break (1069)
|
Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/22/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that, before a procedure, when opening the meniscus mender ii, there was an disconnection of the lasso handle.No patient involvement reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
|
Manufacturer Narrative
|
Additional information on d8 and d9.H3, h6: the reported device was returned to the designated complaint unit for independent evaluation.It was determined the device contributed to the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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.A review of the device drawings found a stress relief collar is now attached at the connection between the shaft and the hub of the suture capture loop.This design change was implemented as a result of a corrective action initiated to address the reported issue.A visual inspection of the returned device found that it is not in its original packaging.One of the suture loops is detached between the hub and the shaft, but the shaft was not returned.There is debris on the needles.A review of the customer provided image finds the complaint device, with one of the loop retrievers fractured at the hub resting on the product box.The complaint was confirmed, and the root cause was associated with device design.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.A corrective action for this failure mode is in place.H10: h2: correction on h6 (health effect - clinical code and health effect - impact code).
|
|
Search Alerts/Recalls
|
|
|