MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE 5.5MM SER 3000; SAW, POWERED, AND ACCESSORIES

Model Number	7206010
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopic knee procedure, the dyonics bone cutter blade failed.The console alarmed, the device was removed and the scrub nurse was not happy with the end of the bone cutter.The procedure was completed without surgical delay using the same device.No patient complications were reported.As per preliminary investigation results, burrs and damage were found to the blade edge of the inner blade.Moreover, the outer blade has a metal shaving at the lower front lip.There is bio debris in and on the device.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual evaluation of the device showed the correct color identifications per the drawing.There are burrs and damage to the blade edge of the inner blade and has drag marks across the back.The outer blade has a metal shaving at the lower front lip.There is bio debris in and on the device.A functional evaluation showed that manually turning the inner blade had drag to it but could rotate a full 360 degree.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that may have contributed to the reported event include excessive ¿side-loading¿ on the blade during use may, in extreme cases, result in wear and degradation of the inner blade.Based on the results of the product evaluation the metal shavings were a result of the ¿damage to the blade edge of the inner blade.¿ the radius blade is made of 304l sst.The radius blade is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond the reported possible retained particles could not be definitively determined.Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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 complaint history review found similar reported events.The instructions for use was 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.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that during an arthroscopic knee procedure, the dyonics bone cutter blade failed.The console alarmed, the device was removed and the scrub nurse was not happy with the end of the bone cutter.The procedure was completed without surgical delay using the same device.No patient complications were reported.As per investigation results, burrs and damage were found to the blade edge of the inner blade.Moreover, the outer blade has a metal shaving at the lower front lip.There is bio debris in and on the device.

• Brand Name: FULL RADIUS BLADE 5.5MM SER 3000
• 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: 15495768
• Report Number: 1219602-2022-01447
• Device Sequence Number: 12072847
• Product Code: HAB
• UDI-Device Identifier: 03596010440235
• UDI-Public: 03596010440235
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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: 03/07/2026
• Device Model Number: 7206010
• Device Catalogue Number: 7206010
• Device Lot Number: 50925587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown