MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 4.0MM ELITE STONECUTTER BURR; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200728

Device Problems Overheating of Device (1437); Temperature Problem (3022)

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

Event Date 10/23/2018

Event Type  malfunction  

Event Description

It was reported that the device was overheating.No patient injury was reported.

Manufacturer Narrative

One (b)(4) dyonics 4.0mm elite stonecutter burr device returned.The product sluff chamber and adapter body has symptoms of melting.Noisy/grinding and overheating/melted material conditions have been found to be consistent with the device being tested/run without or with inadequate suction/irrigation.This device is not intended to be engaged without suction either.Irreversible damage may occur to blades or burrs if they are run without the flow of irrigation (dry).This can cause bone or tissue fragments to not be excised efficiently.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.There is physical evidence of bone/tissue and/or metal shavings not excising efficiently.As a result, binding and melting occurred.Root cause related to the manufacture of the device was not confirmed.Correction.

Event Description

It was reported that the dyonics was overheating.A backup device was available to complete the procedure with no delay and no patient injuries.

• Brand Name: DYONICS 4.0MM ELITE STONECUTTER BURR
• 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: 8080917
• MDR Text Key: 127543352
• Report Number: 1219602-2018-01577
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010578068
• UDI-Public: 03596010578068
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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