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

Catalog Number 7210976

Device Problem Material Opacification (1426)

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

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that, during an acl plasty surgery, while using the motor drive unit to debride the notch, it was noticed that the 4.5mm incisor plus elite blade was releasing metallic flake-shaped particles in the joint.The surgeon ¿washed¿ a lot to make the flakes going out of the joint; then, he used as well a grasp to get out the flakes that could not be vacuumed.A 3.5mm incisor plus elite was used instead to complete the procedure.The surgery was not significantly delayed.The patient was not injured.

Manufacturer Narrative

Nine total 7210976 disposable 4.5mm incisor plus elite blades, some used for treatment, were returned for evaluation.Two related complaints were opened.They stated: ¿the blade was releasing metallic flake-shaped particles in the joint.¿ there were two used items.The rest returned were new unopened product.The metallic debris reported was from surface damage caused during rotation of the inner blade.Skived wear bands were evident on the inner blade¿s outer diameter from contact abrasion.The rotational circles were visible by eye.The shedding is attributed to inadvertent side load pressure and inadequate excision.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.Do not allow the rotating portion of any blade or burr to touch any metallic object such as a cannula or arthroscope.Damage to both instruments is likely.Damage to the blade can range from a slight distortion or dulling of the blade edge to actual fracture of the tip in vivo.If such contact does occur, inspect the tip.If there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately.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).¿ no root cause related to the manufacturing of the device was confirmed.Product met specifications upon release to distribution.

Manufacturer Narrative

One single 7210976 disposable 4.5mm incisor plus elite blade was reported on.It used for treatment but was not returned for evaluation.This product is sold as a box of six-pack.They are not intended to be sold individually.Due to product unavailability, the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were limited without evaluation of physical product.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.This blade has a maximum rotational speed of 5000rpm vs.Other popular blade products that have speeds of up to 10,000rpm.Shedding has been found consistent with inadvertent pressure applied during use which causes wear bands on the inner blade surface which then sheds.Per instruction 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).¿ product met specifications upon release to distribution.

• 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 boulevard; mansfield MA 02048
• MDR Report Key: 8843495
• MDR Text Key: 152710252
• Report Number: 1219602-2019-00900
• 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,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2024
• Device Catalogue Number: 7210976
• Device Lot Number: 50779785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1