|
Model Number OM-6500 |
Device Problem
Firing Problem (4011)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/11/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that during a rotator cuff repair, the opus speedscrew implant failed; once inserted, it was not possible to block the suture in the anchor.The device was removed from the patient.The procedure was successfully completed without a significant delay using a back up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
|
Manufacturer Narrative
|
The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows no manufacturing abnormalities.The anchor is still attached and loaded with suture.A functional evaluation revealed sutures were loaded previously, during testing the anchor was able to be deployed.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 complaint history review concluded this was a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.
|
|
Search Alerts/Recalls
|
|
|