MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE 3.5MM DISP; SAW, POWERED, AND ACCESSORIES

Model Number	7205305
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a knee arthroscopy using the radius blade metal particles were visible on camera, extensive washing was performed.The procedure was completed without surgical delay using a smith and nephew back up device.No further complications were reported.
Event or Problem Description
It was reported that during a knee arthroscopy using the radius blade metal particles were visible on camera, extensive washing was performed.The procedure was completed with non-significant surgical delay using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
Correction in b5.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual evaluation showed that the blister tray with the identifying information was returned with the batch number of the complaint on the lidstock.There are multiple abrasion marks along the inner blade shaft.Two of the areas appear to have had static debris for multiple rotations.There is bio debris inside the inner shaft blade opening.A functional evaluation showed that the device functioned as intended in all modes on a control system.There were no foreign or metal flakes when tested in clear solution.The complaint was confirmed and the root cause was associated with component failure.Factor that may have contributed to the reported event is insufficient irrigation during use.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.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.No containment or corrective actions are recommended at this time.

• Brand Name: FULL RADIUS BLADE 3.5MM DISP
• 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: 15838427
• Report Number: 1219602-2022-01777
• Device Sequence Number: 6909632
• Product Code: HAB
• UDI-Device Identifier: 03596010251336
• UDI-Public: 03596010251336
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/17/2023

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 Model Number: 7205305
• Device Catalogue Number: 7205305
• Device Lot Number: 51028968
• 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: 10/31/2022
• Supplement Date Received by Manufacturer: 01/17/2023; 01/17/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 01/17/2023; 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown