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

Catalog Number 7210976

Device Problem Detachment Of Device Component (1104)

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

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during a knee arthroscopy, the little metal plates came off of the shaverblade.

Manufacturer Narrative

An evaluation of the edgeform indicates that one of the distal teeth of the inner blade edgeform have been worn away.This tooth wear appears to be caused by an impact with the outer edgeform.The outer edgeform shows similar damage.A functional inspection was performed and the inner blade did not rotate freely within the outer blade, friction was felt in the unloaded condition.All indications point to an excessive side-load being applied during use.Per the devices ifu ¿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.¿ no root cause related to the manufacture of the device can be established.No further investigation is warranted at this time.

• Brand Name: INCISOR PLUS ELITE BL,4.5 DS
• 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 w. william cannon; austin, TX 78735 ; 5123585706
• MDR Report Key: 6084130
• MDR Text Key: 59598607
• Report Number: 1219602-2016-01237
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7210976
• Device Lot Number: 50390514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR