MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM PLATINUM FLYER BLADE; SAW, POWERED, AND ACCESSORIES

Model Number 72205292

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that, during an acl knee reconstruction and meniscus debridement, the platinum flyer blade 4.0mm did not remove the tissue from the meniscus as expected.The procedure was completed with a 4.5mm incisor plus elite device.A delay equal to or less than 30 minutes was reported, no further complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.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 review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: 4.0MM PLATINUM FLYER BLADE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11781366
• MDR Text Key: 249238542
• Report Number: 1219602-2021-01033
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 00885556764473
• UDI-Public: 00885556764473
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

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
• Device Operator: Health Professional
• Device Model Number: 72205292
• Device Catalogue Number: 72205292
• Device Lot Number: 50888788
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other