MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM PLATINUM FLYER BLADE; ARTHROSCOPE

Model Number	72205292
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
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, the inner lumen of the flyer blade broke off inside the knee.The pieces were removed with an arthroscopic grasper.The procedure was completed with a non-significant surgical delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was returned for evaluation.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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.This case reports, the inner lumen of the shaver broke off inside the patient¿s knee.Per case correspondence, all pieces were retrieved with an arthroscopic grasper and confirmed by x-ray.Per the product review history ¿no abnormalities were reported on this device during manufacture that would have contributed to the reported event.¿ the procedure was completed with a non-significant procedural delay using a backup device.It has been communicated that patient information is not available.Patient impact beyond that which was reported could not be determined.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A visual inspection found the blade returned without original packaging with the inner blade separate from the outer blade assembly.The distal end of the inner blade was missing a piece of the edgeform that had broken off.It was determined the device contributed to the reported event.The complaint was confirmed and the root cause was associated with an unintended use of the device.Factors that may have contributed to the reported event include an unintended excessive force during use, contact with another source, or excessive side-loading.No containment or corrective actions are recommended at this time.

• Brand Name: 4.0MM PLATINUM FLYER BLADE
• Common Device Name: ARTHROSCOPE
• 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: 14476207
• Report Number: 1219602-2022-00776
• Device Sequence Number: 5335950
• Product Code: HRX
• UDI-Device Identifier: 00885556764473
• UDI-Public: 00885556764473
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K172092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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 Expiration Date: 10/05/2026
• Device Model Number: 72205292
• Device Catalogue Number: 72205292
• Device Lot Number: 50970262
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown