MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER 2.9 MAG-MINI DISP. BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number	72201518
Medical Device Problem Codes	Break (1069); Dent in Material (2526); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, a white material of the tip of the abrader torn, it was part of the inner blade.And it also broke on the upper part of the blade.The procedure was completed without delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H6: the reported device was received for evaluation.A visual inspection revealed that it is not in its original packaging.The white polyester shrink tubing on the inner shaft is cut and scuffed.The inner shaft is fractured toward the distal end.The outer shaft is dented at the cutting window and the interior of the hub is damaged at the insertion point for the inner shaft.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 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 has been associated with unintended use of the device.Factors that could have contributed to the failure include an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.

• Brand Name: ABRADER 2.9 MAG-MINI DISP. 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: 18872226
• Report Number: 1219602-2024-00439
• Device Sequence Number: 7721061
• Product Code: HAB
• UDI-Device Identifier: 03596010621672
• UDI-Public: 03596010621672
• 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
• Report Date (Section B): 04/25/2024

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: 72201518
• Device Lot Number: 51037243
• 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: 02/19/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 03/10/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2022
• 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