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

Model Number 72200730

Device Problems Overheating of Device (1437); Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One 72200730 dyonics 4.0mm acromioblaster elite burr device used for treatment, was returned for evaluation.Visual inspection confirmed the device was run with inadequate or no suction and irrigation.Insufficient cooling, fused the sluff chamber and adapter body together.To keep the blade adequately free of debris and cooled, suction and irrigation adjustment is the user¿s responsibility.Insufficient irrigation causes bone and tissue fragment build up leading to rotational issues.Smith and nephew dyonics disposable endoscopic blades may only be used with smith and nephew hand pieces per instructions for use ¿irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).¿ and also states: ¿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).¿ nor is the device intended to be engaged without suction.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.Root cause related to the manufacture of the device was not confirmed.No further investigation is warranted at this time.

Event Description

It was reported that during a procedure, the tip of burr was bent when the blade was using it.It is unknown if there was a delay or how the procedure was finished.No patient injury or other complications were reported.Results of investigation have shown that the device overheated which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: DYONICS 4.0MM ELITE ACROMIOBLASTER BURR
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10566559
• MDR Text Key: 207919741
• Report Number: 1219602-2020-01447
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010578082
• UDI-Public: 03596010578082
• 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
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200730
• Device Catalogue Number: 72200730
• Device Lot Number: 50832082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Date Manufacturer Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• 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