MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BL CONCAVE EP-1 (BX 3); SAW, POWERED, AND ACCESSORIES

Catalog Number	7205335
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopy, the full radius blade had wear and remnants of foreign bodies of metal from the blade, and small debris in the joint.The surgeon locked at the tip of the blade and noticed wear on the inside of the blade.The procedure was finished with the same device.No delay or further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
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 is damaged at the flexible portion.The distal tip shows degradation and the inner shaft was unable to be removed from the outer shaft without further damage.There is biological debris on the returned device.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 instructions for use, dyonics disposable endoscop blades document, 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.The root cause was associated with unintended use of the device.Factor that could have contributed to the reported event is insufficient irrigation during use.No containment or corrective actions are recommended at this time.

• Brand Name: FULL RADIUS BL CONCAVE EP-1 (BX 3)
• 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: 17725356
• Report Number: 1219602-2023-01737
• Device Sequence Number: 7219754
• Product Code: HAB
• UDI-Device Identifier: 03596010251626
• UDI-Public: 03596010251626
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 03/22/2024

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: 7205335
• Device Lot Number: 51044811
• 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: 08/25/2023
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 31 YR
• Patient Sex: Male