MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 5.5MM INCISOR PLUS PLATINUM SERIES; SAW, POWERED, AND ACCESSORIES

Model Number	72203519
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a knee arthroscopy, the dyonics incisor blade left a lot of metal debris in the joint.Most of the metal debris was retrieved from the patient with suction.The procedure was completed with a non-significant surgical delay using a back-up device.No further complications were reported.The patient's current status is well.
Additional Manufacturer Narrative
H10: internal complaint reference case (b)(4).
Additional Manufacturer Narrative
H6, health effect - impact code updated.H3, h6: a device deficiency was identified; however, the root cause of the reported event could not be determined since the device was not received for evaluation.An analysis of the device image shows wear on the metal blade.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 no 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 clinical review states that an undated intraoperative photo was provided for review and confirms the reported.Based on the information provided no clinical factors were found which would have contributed to the reported events.The materials are well stablished.The blade is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: 5.5MM INCISOR PLUS 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: 16870991
• Report Number: 1219602-2023-00647
• Device Sequence Number: 20319489
• Product Code: HAB
• UDI-Device Identifier: 00885554027846
• UDI-Public: 00885554027846
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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 Model Number: 72203519
• Device Catalogue Number: 72203519
• Device Lot Number: 51012017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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