MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE BLADE 5.5MM DSPL 6BX; ARTHROSCOPE

Model Number 72200081

Device Problems Material Fragmentation (1261); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a knee arthroscopy procedure, shortly after use began, the incisor blade made a noise as if it was seized and then dispersed metal particles into the knee.The device was removed from the patient and the particles were removed by suction.It is unknown how was the procedure completed and if there was a surgical delay due to the reported event.No further complications were reported.

Manufacturer Narrative

H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were 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 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.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

Manufacturer Narrative

H6, medical device problem code updated.H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was returned in original packaging with the batch number of the complaint on the label.The color scheme matches the print.The outer shaft shows signs of use.One tooth on the outer blade and one tooth on the inner blade is deformed.The deformed inner tooth will not allow the blade to spin or be removed from the outer blade.A functional evaluation could not be performed due to the deformed teeth.A complaint history review found no 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.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 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.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include insufficient irrigation or lack of irrigation.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.

• Brand Name: INCISOR PLUS ELITE BLADE 5.5MM DSPL 6BX
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16547094
• MDR Text Key: 311331568
• Report Number: 1219602-2023-00382
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010555687
• UDI-Public: 03596010555687
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K172092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200081
• Device Catalogue Number: 72200081
• Device Lot Number: 51037292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other