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

Catalog Number 72203013

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 03/28/2019

Event Type  malfunction  

Event Description

It was reported that when using this shaver during a knee arthroscopy and debridement of the meniscus, the shaver left behind black stripes/streaks residue on the white cartilage and the meniscus.There was no significant delay or patient injuries reported but it is unknown if a backup was available to complete the procedure.No further information is available.

Manufacturer Narrative

One 72203013 disposable 4.5mm incisor plus platinum blade returned.The complaint stated: ¿the shaver left behind black stripes/streaks residue inner blade seemed to be stuck on initial use.¿ there were various factors that contributed to the observation.Damage being the primary catalyst.The blade is considerably bowed.This has caused skiving on the inner blade¿s outer surface where contact has been made with the outer blade.This surface condition indicates excess pressure/force was applied to the device causing the inner blade to bind with the outer.¿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 blade¿.Metal shavings result from pressure during rotation.Irreversible damage may occur to blades or burrs if they are run without the flow of irrigation (dry).¿ binding and seizing can occur due to matter; tissue, bone, or metal shaving fragments not being efficiently excised.In addition, visual inspection showed blue-black tarnish of the platinum finish was present.The silver tarnish was loosened due to friction between the blade components.Remaining un-excised matter indicated less than ideal suction/irrigation to accommodate build-up of matter within the blade.The silver plating process is used to produce a device with less friction to improve performance of the device.Silicone is used for additional lubrication between inner and outer blades.Silicone and silver may is a visual observation but do not have an adverse effect on patient safety.Observations are monitored through engineering.Testing found that the results to be cosmetic.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8491879
• MDR Text Key: 141324311
• Report Number: 1219602-2019-00397
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010655660
• UDI-Public: 03596010655660
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2023
• Device Catalogue Number: 72203013
• Device Lot Number: 50759023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 04/19/2019
• Supplement Dates FDA Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2018
• 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