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

Catalog Number	72200722
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the tip of the blade elite abrader was detached.The procedure was completed using a back-up device.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found both the inner and outer burrs laying on a surface.The tip of the inner burr is detached.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.The root cause could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include excessive force or excessive sideloading to the device.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection revealed that it is not in its original packaging.The distal end of the inner shaft of the device is fractured from the shaft at the proximal end of the distal portion of the shaft just behind the opening for the slough chamber.An evaluation of the customer provided images found both the inner and outer burrs laying on a surface.The tip of the inner burr is detached.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 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.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences.Other factors, that can contribute to the complaint event, include an application of unintended inappropriate or excessive force to the device.Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.

• 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: 19525007
• Report Number: 1219602-2024-01277
• Device Sequence Number: 18017638
• Product Code: HAB
• UDI-Device Identifier: 03596010578006
• UDI-Public: 03596010578006
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2024

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: 72200722
• Device Lot Number: 51063045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 06/25/2024; 09/02/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 06/26/2024; 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2022
• 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: Unknown