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

Model Number	72200726
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unknown procedure, there was a metal shavings and debris into the patient and it was successfully removed with suction straight away.Procedure was successfully completed with the same device.No significant delay was reported with no patient complications.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the returned device and the reported incident.The customer provided images confirm the product identification information and identify metal shavings in the surgical site.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.A review of the instructions for use found: 1) do not resterilize.For single use only.Discard any open, unused product.Do not use after the expiration date.2) do not allow the rotating portion of any blade or burr to touch any metallic object such as a cannula or arthroscope.Damage to both instruments is likely.The complaint was confirmed and the root cause was associated with a component failure.Factors that could have contributed to the reported event include excessive force or contact with another device.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H11: corrected information in h6 (health effect - impact code).
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was returned without original packaging.The distal end of the outer shaft was damaged.A functional evaluation revealed the device functioned as intended.No grinding while rotating clockwise, counter clockwise, or while oscillating.There was a relationship found between the device and the reported event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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 clinical review states that one intra-operative photo was provided for review and confirms the debris in the surgical field.Per complaint details the metal debris was removed from patient.No delay or patient injuries are being reported.Since no harm is being alleged, no further clinical assessment is warranted.The root cause was associated with component failure.Factors that could have contributed to the reported event include excessive force on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: DYONICS 4.0MM ELITE NOTCHBLSTR ABRD 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: 10814569
• Report Number: 1219602-2020-01813
• Device Sequence Number: 19855325
• Product Code: HAB
• UDI-Device Identifier: 03596010578044
• UDI-Public: 03596010578044
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2025
• Device Model Number: 72200726
• Device Catalogue Number: 72200726
• Device Lot Number: 50857117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 01/14/2021; 02/27/2024; 02/27/2024
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 01/18/2021; 02/29/2024; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown