MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE 4.0 ELITE ABRADER 6/BX; SAW, POWERED, AND ACCESSORIES

Model Number	72200722
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an elbow arthroscopy, a burr on a short sheath was used.When starting to use the burr, it was noted that small fragments of metal were present in the elbow cavity, they were not visible to the naked eye, it was magnified by an arthroscopy camera and tv screen.The surgeon stopped using the burr and swapped it to a shaver.They tried to remove as much of the metal fragment as possible, they used a magnetic screwdriver tip to try and pick up some of the remaining fragments.They were unable to determine if fragments came from the burr or the sheath.A non-significant delay was reported.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 h3, h6: 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.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.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.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The inner shaft of the device has scratches and some flaked metal near the proximal end of the inner shaft.The outer shaft shows no damage and both hubs were returned intact.A functional assessment of the device found that when used with the included outer shaft and a reference device the inner shaft made a grinding noise.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 and long-term implantation data is not available.The patient impact beyond the reported possible retained particles could not be definitively determined.Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.A complaint history review found no similar reported events.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include insufficient irrigation or lack of irrigation.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.H11: h2: corrected data on b5 and h6 (health effect - impact code).
Event or Problem Description
It was reported that during an elbow arthroscopy, an elite abrader burr on a short sheath was used.When starting to use the burr, it was noted that small fragments of metal were present in the elbow cavity, they were not visible to the naked eye, it was magnified by an arthroscopy camera and tv screen.The surgeon stopped using the burr and swapped it to a shaver.They tried to remove as much of the metal fragment as possible, they used a magnetic screwdriver tip to try and pick up some of the remaining fragments.They were unable to determine if fragments came from the burr or the sheath.A non-significant delay was reported.No further complications were reported.

• Brand Name: BLADE 4.0 ELITE ABRADER 6/BX
• 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: 16586727
• Report Number: 1219602-2023-00399
• Device Sequence Number: 4694109
• Product Code: HAB
• UDI-Device Identifier: 03596010578006
• UDI-Public: 03596010578006
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/31/2023

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 Expiration Date: 07/09/2026
• Device Model Number: 72200722
• Device Catalogue Number: 72200722
• Device Lot Number: 50952138
• 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: 03/02/2023
• Supplement Date Received by Manufacturer: 06/06/2023; 10/27/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 06/07/2023; 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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: Other; Required Intervention
• Patient Sex: Unknown