MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM FULL RADIUS PLATINUM SERIES; SAW, POWERED, AND ACCESSORIES

Catalog Number	72203521
Medical Device Problem Codes	Flaked (1246); Noise, Audible (3273)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that, during a knee arthroscopy, when introducing the full radius platinum blade into the joint space, a dark powdery substance was left on the soft tissue it came in contact with.The procedure was completed with the same device, no delay and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, h6: the reported device was received for evaluation.A visual inspection found debris on it.There were wear patterns from use and black markings on the inner blade.Two additional devices from the same lot number were received in packaging and tested.There were black markings on the inner blades.A functional evaluation revealed the devices were noisy.The black markings could be removed from the inner blade with significant force.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.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 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 review of the procedure found that each component should be tested and visually inspected for all non-conforming attributes defined in the procedure.A clinical review states that it has not been reported that the shaver tip shedding/debris from the full radius platinum blade were removed from the patient.The ifu for the blades does caution that ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly.¿ the material is approved for short-term contact; however, no data for long-term exposure is available as the instrument is manufactured and intended as an externally communicating device, not intended for implantation.The patient impact beyond possible local irritation/discomfort, and/or migration of the possible retained metal debris cannot be determined.The root cause was associated with unintended use error caused or contributed to event.Factors that may have contributed to the reported event include excessive ¿side-loading¿ on the blade during use may, extreme cases, result in wear degradation and a noisy blade.No containment or corrective actions are recommended at this time.Internal complaint reference: (b)(4).

• Brand Name: 4.5MM FULL RADIUS PLATINUM SERIES
• 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: 11999233
• Report Number: 1219602-2021-01358
• Device Sequence Number: 16996974
• Product Code: HAB
• UDI-Device Identifier: 00885554024333
• UDI-Public: 00885554024333
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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: 02/09/2026
• Device Catalogue Number: 72203521
• Device Lot Number: 50920994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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; Other
• Patient Sex: Unknown