MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE 5.5MM DSPL. EP-1; SAW, POWERED, AND ACCESSORIES

Model Number	7205307
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a shoulder arthroscopy, the physician visualized metallic fragments in the patient's cavity (as powder) at the time of using the full radius blade.The fragments were removed from the patient with the suction of the pump.The procedure was completed without surgical delay using a back-up device.No further complications were reported.The patient current status is stable.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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 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.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in any original packaging.The device color scheme matches the drawing.The inner blade has scoring around the proximal end of the tube.The blade window edges show signs of wear.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 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.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event may have been insufficient irrigation during use.No containment or corrective actions are recommended at this time.

• Brand Name: FULL RADIUS BLADE 5.5MM DSPL. EP-1
• 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: 15843455
• Report Number: 1219602-2022-01789
• Device Sequence Number: 6901363
• Product Code: HAB
• UDI-Device Identifier: 03596010251350
• UDI-Public: 03596010251350
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2023

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 Model Number: 7205307
• Device Catalogue Number: 7205307
• Device Lot Number: 51019114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 02/07/2023; 10/20/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 02/08/2023; 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male