MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED INCISOR PLUS BL (BX6); SAW, POWERED, AND ACCESSORIES

Catalog Number	7205345
Medical Device Problem Codes	Material Fragmentation (1261); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an elbow debridement, the blade produced slight iron filings and soon became clogged.After unsuccessful attempts at cleaning and dredging, a double-tooth blades were replaced and used as a back up device to complete the operation.The shred fragments were removed from the patient using suction.There was a delay less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
A device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.An image evaluation was performed and found the device inside the tray.No damage can be seen.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.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.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If any additional information related to this event is received in the future, this investigation will be reopened for further assessment.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection revealed the device was returned in original packaging with the batch number of the complaint on the label.The color scheme of the device matches the print.The blade has minimal usage.No scoring or damage to the inner or outer blades.A functional evaluation was performed on the returned device and found that when connected to a reference mdu, it spins as intended without grinding, seizing, or unexpected noise.No particles were observed.Fluid flowed through the cannula with no blockage.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.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.An evaluation of the customer provided image showed the device inside the tray.No damage can be seen.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include include excessive force to the device or excessive side loading.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: BOXED INCISOR PLUS BL (BX6)
• 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: 19922342
• Report Number: 1219602-2024-01663
• Device Sequence Number: 18171169
• Product Code: HAB
• UDI-Device Identifier: 03596010251688
• UDI-Public: 3596010251688
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 10/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7205345
• Device Lot Number: 51088536
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2024
• Supplement Date Received by Manufacturer: 09/12/2024; 09/27/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/16/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2022
• 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
• Patient Sex: Male