MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM INCISOR PLUS PLATINUM BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number 72203013

Device Problem Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2019

Event Type  malfunction  

Event Description

It was reported that during a knee surgery there was metal debris when used.A backup device was used to complete the surgery.No significant delay or patient injury reported.

Manufacturer Narrative

One 72203013 disposable 4.5mm incisor plus platinum blade used for treatment, was returned for evaluation.There were signs of inner and outer blade contact with each other.The outer blade had been slightly bowed from pressure.There were light rotational scoring marks left on the surface of the inner blade.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Per instructions for use: ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly.Make sure the hand piece is off while changing blade tip position.Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running.Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).¿ fine particulate can be created from friction during rotation which is a surface skiving issue.It is aligned with inadvertent pressure applied and/or insufficient fluid irrigation.Binding and seizing can occur due to matter; tissue, bone, or metal shaving fragments not being efficiently excised.The blade had light drag, but was tested to confirm functionality.The product connected, ran in forward, reverse and oscillating.It switched between modes with no issue.There were no error messages indicated on the control panel.Product met specifications upon release to distribution.Observations are monitored through engineering.

• Brand Name: 4.5MM INCISOR PLUS PLATINUM BLADE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9142564
• MDR Text Key: 160842982
• Report Number: 1219602-2019-01191
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010655660
• UDI-Public: 03596010655660
• 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: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Catalogue Number: 72203013
• Device Lot Number: 50797383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1