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

Model Number	72200724
Medical Device Problem Codes	Overheating of Device (1437); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy two blades made a strange noise.It occurred after about 10 seconds of rotation.The procedure was completed using an unknown device.It is unknown if there was a delay.No patient complications were reported.Overheating was reported on device with the lot number 50943904.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.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.A visual inspection revealed the device was returned outside of original packaging.Signs of overheating and melting on the sluff chamber.No other physical damage visible.A functional evaluation revealed the device functions, but makes noise due to sluff chamber becoming melted.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include rotating the device at speeds faster than intended, running the device for long periods of time without allowing it to cool, or excessive force on the device creating excess friction.No containment or corrective actions are recommended at this time.H11: corrected information in a1 (should be read in blank), b5, and h6 (health effect - impact code).
Event or Problem Description
It was reported that during an arthroscopy, the blade made a strange noise and overheated.It occurred after about 10 seconds of rotation.The procedure was completed using an unknown device.It is unknown if there was a delay.No patient complications were reported.

• 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
• 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: 14470601
• Report Number: 1219602-2022-00774
• Device Sequence Number: 20008434
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

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 Expiration Date: 06/01/2026
• Device Model Number: 72200724
• Device Catalogue Number: 72200724
• Device Lot Number: 50943904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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