MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE BL 4.5MM DSPL DYO PW; SAW, POWERED, AND ACCESSORIES

Model Number 7210976

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 10/14/2020

Event Type  malfunction  

Event Description

It was reported that during a knee arthroscopy procedure, the blade was used and made lots of metal debris in the joint.Pieces were successfully removed from the patient with grasper and shaver suction.Backup device was available to complete the procedure.No significant delay and no patient 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 device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A review of the complaint found that all the pieces were successfully removed from the patient using a grasper and a shaver suction.Since there was no significant delay or patient complication reported, no further clinical assessment is warranted.A visual inspection found that five devices were returned.Three of them were returned unopened.A visual inspection of the two opened devices found biological debris on the tip indicating use.A microscopic inspection of all returned devices found no evidence of shearing, dimpling, or nicking that would indicate metal-on-metal contact.A functional evaluation of all five devices found no issues.All devices operated as expected at low and high speeds.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.Based on our investigations the failure mode cannot be confirmed.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution and to speculate about factors which could have contributed to the reported event.The root cause of the problem stays undetermined.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.This investigation is considered closed.[1]: studers p, belajevs d, jurkevics v, likums p.Ten to fifteen-year clinical and radiographic follow-up with a third-generation cementless stem in a young patient population.Int orthop.2016 mar;40(3):465-71.Doi: 10.1007/s00264-015-2846-z.Epub 2015 jul 30.Pmid: 26224612.

• Brand Name: INCISOR PLUS ELITE BL 4.5MM DSPL DYO PW
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10797368
• MDR Text Key: 214992735
• Report Number: 1219602-2020-01779
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010532626
• UDI-Public: 03596010532626
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7210976
• Device Catalogue Number: 7210976
• Device Lot Number: 50828121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention