MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM INCISOR PLUS PLATINUM BLADE; SAW, POWERED, AND ACCESSORIES

Model Number	72203013
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during knee arthroscopy, the incisor plus platinum blade was leaving black residue within the patient's joint.The doctor completed the procedure with no further complication reported.It is unknown if there were delays or how was the procedure completed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 h3, h6: the reported device was received for evaluation.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 came off no black residue.Device passed all functional test.A complaint history review concluded this was a repeat issue.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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.This case reports that following the use of the incisor plus platinum blade, black residue was noted in the patient's joint and it is unknown if the residue was retrieved from the patient.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Based on the limited information provided, the root cause for the reported events could not be determined.It is unclear if the device instructions for use was adhered to as it was noted that ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation ¿¿ / ¿periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site¿¿ / ¿irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).The material 304 stainless steel with 17-4 hardened are manufactured and intended as an externally communicating device, not approved for implantation; therefore, long-term implantation data is not available.If retained the patient impact beyond possible corrosion, local irritation/discomfort, and/or migration cannot be determined.No further medical assessment can be rendered at this time.It was determined the device did not contribute to the reported event.The complaint was not confirmed, 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: 4.5MM INCISOR PLUS PLATINUM BLADE
• 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: 11121019
• Report Number: 1219602-2021-00049
• Device Sequence Number: 3595453
• Product Code: HAB
• UDI-Device Identifier: 03596010655660
• UDI-Public: 03596010655660
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: 09/07/2025
• Device Model Number: 72203013
• Device Catalogue Number: 72203013
• Device Lot Number: 50894018
• 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: 12/11/2020
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown