SMITH & NEPHEW, INC. DYONICS 5.5MM ELITE ACROMIONIZER BURR; SAW, POWERED, AND ACCESSORIES
|
Back to Search Results |
|
Model Number 72200725 |
Device Problem
Flaked (1246)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/15/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).
|
|
Event Description
|
It was reported that during use instruments inside the patient in an arthroscopy, the blade shredded off, they managed to remove the debris but the inner blades seemed to become stuck and therefore was unable to rotate.All remaining material was removed from surgical site.The procedure was completed with a s+n back-up device.No significant delay was reported, and no other complications were reported.
|
|
Manufacturer Narrative
|
H10: internal complaint reference: case-(b)(4).H3, h6: ¿the device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed the device was received outside of original packaging.The distal tip of the inner blade appears to have what appears to be sluff chamber debris.No physical damage visible to the distal tip of the inner blade or outer blade.The sluff chamber appears to have started melting together.A functional evaluation revealed the device functioned clockwise, counter clockwise, and while oscillating as intended without excessive noise or grinding.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 an isolated event.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 confirmed.Factors that could have contributed to the reported event include running the device with inadequate or no suction and irrigation.No containment or corrective actions are recommended at this time.
|
|
Search Alerts/Recalls
|
|
|