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

Catalog Number 72200725

Device Problems Melted (1385); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event 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.

Manufacturer Narrative

H11: h2: the correct aware date on g2 for the initial report is (b)(6)2023.

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
• 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: 17455628
• MDR Text Key: 320570717
• Report Number: 1219602-2023-01405
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010578037
• UDI-Public: 03596010578037
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200725
• Device Lot Number: 51070896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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