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

Catalog Number	72200730
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during surgery, the blade made a noise when the device was rotating.The procedure was completed without using the device.Delay or patient injuries were not reported.
Additional Manufacturer Narrative
One 72200730 dyonics 4.0mm acromioblaster elite burr device returned.The complaint stated: ¿the blade made a noise when the device was rotating.¿ visual inspection confirmed no obvious damage to the product.The blade was functionally tested with a dyonics power control unit with a powermax elite handset.There was no observation out of the norm.It ran in forward, reverse and oscillating.It switched between modes with no issue.There was no error messages indicated on the power control panel.Smith and nephew dyonics disposable endoscopic blades may only be used with smith and nephew hand pieces.Returns for noise and screeching has been found to be consistent with the device being ¿tested¿ without or with insufficient irrigation.¿irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).And it 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.Root cause related to the manufacture of the device was not confirmed.

• Brand Name: DYONICS 4.0MM ELITE ACROMIOBLASTER BURR
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8368958
• Report Number: 1219602-2019-00239
• Device Sequence Number: 1098606
• Product Code: HAB
• UDI-Device Identifier: 03596010578082
• UDI-Public: 03596010578082
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 72200730
• Device Lot Number: 50724394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1