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

Catalog Number	7206010
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a left shoulder scope, three radius blades were flaking off metal shavings inside the patient where the external sheath of the shaver and the internal sheath were rubbing together.The metal flakes were retrieved by suction.The procedure was completed with a s+n back-up device.No delay was reported, and no patient injury or other complications were reported.
Additional Manufacturer Narrative
The shipping information was provided; however, the subject device was not made available to the designated complaint unit and thus a physical product evaluation could not be performed.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.A review of the disposable plating inspection procedure found that the material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.A clinical review states that there were no clinical factors found which would have definitively contributed to the event.The root cause of the reported event could not be determined since the device was not received for evaluation.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is received at a future date, this investigation will be reopened for evaluation.

• 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: 11823143
• Report Number: 1219602-2021-01122
• Device Sequence Number: 13724517
• Product Code: HAB
• UDI-Device Identifier: 03596010440235
• UDI-Public: 03596010440235
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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: 03/07/2023
• Device Catalogue Number: 7206010
• Device Lot Number: 50894050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 01/22/2024
• Date Device Manufactured: 09/07/2020
• 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
• Patient Sex: Unknown