SMITH & NEPHEW, INC. BURR 5.5 ABRADER 180 LG HIGH VIS DSPL.; SAW, POWERED, AND ACCESSORIES
|
Back to Search Results |
|
Model Number 72203127 |
Device Problem
Material Integrity Problem (2978)
|
Patient Problem
Injury (2348)
|
Event Date 06/06/2020 |
Event Type
Injury
|
Event Description
|
It was reported that during surgery, the blue plastic part in the distal part of the burr 5.5 abrader seems worn out by the rotation of the stem in the part of the graft, leaving blue whips in the joint and on a gauze.It is unknown whether there was a back up available or delay in the case.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
|
Manufacturer Narrative
|
The reported 5mm abrader burrs, used in treatment, have not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the blue plastic part of the device shed.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: using little to no irrigation while operating the burr.The instruction for use outlines precautionary statements and instructions in during deployment.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.
|
|
Manufacturer Narrative
|
The reported device, used in treatment, was received for evaluation.There was not a relationship found between the returned device and the reported incident.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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.A visual inspection was performed and no deficiencies were observed.A functional inspection was performed and no deficiencies were observed.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
|
|
|