MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 5.5MM ELITE ACROMIONIZER BURR; SAW, POWERED, AND ACCESSORIES

Catalog Number	72200725
Medical Device Problem Codes	Melted (1385); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a procedure, the dyonics burr made a strange noise when it operated, and the tip of the burr melted.The procedure was completed with delay greater than 30 minute using a s+n back up device.No further complications were reported.
Additional Manufacturer Narrative
H11: h2: the correct aware date on g2 for the initial report is (b)(6)2023.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A visual evaluation showed the device was returned in original packaging with the batch number of the complaint on the label.There are no visible deficiencies.A functional evaluation, using a reference control system, showed the device functioned in all modes with no unexpected noises.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint was not confirmed, and the root cause could not be determined.Factors that could have contributed to the reported event include insufficient irrigation or an application of unintended inappropriate or excessive force to the device.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: DYONICS 5.5MM ELITE ACROMIONIZER BURR
• Common Device Name: 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: 17455628
• Report Number: 1219602-2023-01405
• Device Sequence Number: 2709940
• Product Code: HAB
• UDI-Device Identifier: 03596010578037
• UDI-Public: 03596010578037
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2023

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 Catalogue Number: 72200725
• Device Lot Number: 51070896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 08/03/2023; 10/17/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/28/2023; 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown