MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE 3.5MM ELITE FULL RADIUS; SAW, POWERED, AND ACCESSORIES

Model Number	7210751
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during arthroscopy, a blade 3.5mm elite full radius created metal flake.Procedure was resumed, after a non-significant delay (less or equal to 30min), with a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A visual inspection revealed the device was not returned with original packaging and the device has debris on it.No physical damage is visible to the device.A functional evaluation of the returned device found that nothing is missing from device.Device was hooked up and powered up and nothing fell off.Device passed all functional test.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.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.It has not been reported whether the metal flakes from a blade on a 3.5mm elite full radius were removed from inside of the patient.The root cause of the reported issue could not be determined.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of the possible retained metal debris cannot be determined.It was reported the procedure completed without a significant delay or patient harm with a backup device.Since there were no other complications reported, no further clinical/medical assessment is warranted at this time.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

• Brand Name: BLADE 3.5MM ELITE FULL RADIUS
• 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: 12533731
• Report Number: 1219602-2021-02140
• Device Sequence Number: 19182969
• Product Code: HAB
• UDI-Device Identifier: 03596010532596
• UDI-Public: 03596010532596
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 01/31/2023

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: 01/08/2026
• Device Model Number: 7210751
• Device Catalogue Number: 7210751
• Device Lot Number: 50915097
• 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: 09/06/2021
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2021
• 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: Other
• Patient Sex: Unknown