MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 4.0MM ELITE ACROMIONIZER BURR(6); SAW, POWERED, AND ACCESSORIES

Model Number	72200724
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual investigation concluded the reportable event; however, this results will include additional evaluation comments and the entire summary will be shared later by a supplemental mdr.
Event or Problem Description
It was reported that during arthroscopy, the dyonics burr could not be rotated when the device was used.The procedure was successfully completed with a s+n back-up.No patient injuries or delay were reported.Based on the results of investigation the burr overheated and had melted components this makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: one single 72200724 dyonics 4.0mm elite acromionizer burr used for treatment, was returned for evaluation.Ifu confirms precautionary statements and recommendations for proper use of product.Visual evaluation confirmed that the burr had melted components.Overheating, melted material condition is aligned with devices being tested or run without or with inadequate suction and irrigation.Per ifu 1060595: ¿irreversible damage may occur to blades or burrs if they are run without the flow of irrigation (dry).¿ binding and seizing may occur due to bone, tissue or metal shavings, fragments not excising 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.Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).¿ complaint history review for three years prior indicated similar allegations for the product code reported.Batch review was unattainable without a valid lot number reported.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.No further investigation is warranted at this time.

• Brand Name: DYONICS 4.0MM ELITE ACROMIONIZER BURR(6)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10193036
• Report Number: 1219602-2020-00956
• Device Sequence Number: 2464780
• Product Code: HAB
• UDI-Device Identifier: 03596010578020
• UDI-Public: 03596010578020
• 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): 07/09/2020

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 Model Number: 72200724
• Device Catalogue Number: 72200724
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1