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

Catalog Number 72200081

Device Problems Overheating of Device (1437); Activation Problem (4042)

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

Event Date 01/04/2019

Event Type  malfunction  

Event Description

It was reported that during a surgery, the knife did not work properly (difficult rotation).The knife head presented heat release with abnormal friction noises, the device become overheat when this was touched and an error message was displayed.The procedure was successfully complete with the same device.No patient injury or delay in the case were reported.

Manufacturer Narrative

One 5.5mm incisor plus elite blade was returned for evaluation.Visual assessment of the device showed significant cracking of the adapter body.Functional inspection was performed and the inner blade did not rotate freely within the outer blade, friction was felt in the unloaded condition.The blade is bent.The inner blade showed a slight abrasion at the distal tip and damage to the edgeform teeth.The outer blade also showed a slight abrasion and damage to the edgeform teeth.The condition of the device indicates it was subjected to an excessive side load during use.Per the device's 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¿.No root cause related to the manufacture of the device can be established.

Event Description

It was reported that, during an unspecified surgery, the knife did not work properly (difficult rotation).The knife head presented heat release with abnormal friction noises, the device became overheated when this was touched and an error message was displayed.The procedure was successfully complete with the same device.No patient injury or delay in the case were reported.

• Brand Name: INCISOR PLUS ELITE BLADE,5.5MM,DSPL,6BX
• 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: 8234210
• MDR Text Key: 132832271
• Report Number: 1219602-2019-00049
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010555687
• UDI-Public: 03596010555687
• Combination Product (y/n): N
• Reporter Country Code: TS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2022
• Device Catalogue Number: 72200081
• Device Lot Number: 50639960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2017
• 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