MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM BONECUTTER ELECTROBLADE RESECTOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	72202213
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
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 electroblade did not get an energy output when using a coagulation.The procedure was successfully completed with a smith and nephew back-up device.No patient injuries, delays or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h3,h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection revealed that there was some wear and discoloration on the blade, but minimal debris.A functional evaluation concluded that the forward, reverse, and oscillate functions operated as expected.The coagulate function was tested in saline and did not indicate any problems.A review of the device 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 complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

• Brand Name: 4.5MM BONECUTTER ELECTROBLADE RESECTOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11640399
• Report Number: 3003604053-2021-00146
• Device Sequence Number: 3124588
• Product Code: GEI
• UDI-Device Identifier: 00885554015348
• UDI-Public: 00885554015348
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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: 03/31/2023
• Device Model Number: 72202213
• Device Catalogue Number: 72202213
• Device Lot Number: 4991769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1