MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS 2.0 MAG-MINI DISP. BLA; SAW, POWERED, AND ACCESSORIES

Model Number	72201507
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the full radius blade stopped rotating after about 10 minutes of use.After checking the blade, it was noticed that the inner blade broke into pieces.The broken pieces did not fall into the patient.The procedure was completed without delay using an unknown device.No patient complications were reported.
Event or Problem Description
It was reported that during an arthroscopy, the full radius blade stopped rotating after about 10 minutes of use.After checking the blade, it was noticed that the inner blade broke into pieces.The broken pieces did not fall into the patient.The procedure was completed without delay using an unknown device.No patient complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A complaint history review found 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.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection of the returned device found that it is not in its original packaging.The outer sheath is bent and the inner shaft has the distal blade broken off.There is debris on both the sheath and the shaft portion.A functional evaluation could not be performed due to the condition in which the device was received.A review of the customer provided image finds the device outside its packaging with the outer sheath of the device bent and the inner shaft broken.Per case details, no pieces fell into the patient.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, off-axis insertion of the device, lack of irrigation during use, or an impact event inconsistent with normal use.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.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A complaint history review found 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection of the returned device found that it is not in its original packaging.The outer sheath is bent and the inner shaft has the distal blade broken off.There is debris on both the sheath and the shaft portion.A functional evaluation could not be performed due to the condition in which the device was received.A review of the customer provided image finds the device outside its packaging with the outer sheath of the device bent and the inner shaft broken.Per case details, no pieces fell into the patient.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, off-axis insertion of the device, lack of irrigation during use, or an impact event inconsistent with normal use.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.

• Brand Name: FULL RADIUS 2.0 MAG-MINI DISP. BLA
• 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: 14739654
• Report Number: 1219602-2022-00890
• Device Sequence Number: 5583149
• Product Code: HAB
• UDI-Device Identifier: 03596010621689
• UDI-Public: 03596010621689
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2022

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 Expiration Date: 03/07/2024
• Device Model Number: 72201507
• Device Catalogue Number: 72201507
• Device Lot Number: 50925621
• 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: 05/26/2022
• Supplement Date Received by Manufacturer: 07/07/2022; 07/13/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 07/08/2022; 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2021
• 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
• Patient Sex: Unknown