MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BL 4.5MM DSPL. EP-1; SAW, POWERED, AND ACCESSORIES

Model Number	7205306
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during use inside the patient, the shaver was shedding metal shavings into the joint.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found black markings on the distal tip of the inner blade.There was evidence of metal shedding on the inside of the outer blade.A functional evaluation revealed the device operated in the forward, reverse and oscillate modes as expected.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.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 review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed and the root cause was associated with a component failure.Factors that could have contributed to the reported event include sideloading or activation in open air.No containment or corrective actions are recommended at this time.

• Brand Name: FULL RADIUS BL 4.5MM DSPL. EP-1
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11795020
• Report Number: 1219602-2021-01067
• Device Sequence Number: 3846963
• Product Code: HAB
• UDI-Device Identifier: 03596010251343
• UDI-Public: 03596010251343
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 7205306
• Device Catalogue Number: 7205306
• Device Lot Number: 50915046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention