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

Model Number	72202213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a surgery, the electroblade resector outside sheath was loose and came apart.The procedure was successfully completed without a significant delay using a back up device.No 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
H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.The two devices were returned together.Both had considerable debris.The glued joints at the cable input had separated on both devices, exposing the internal wiring and compromising the insulation.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 a repeat issue.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were reviewed and found the following warnings and precautions related to the reported failure: attempts to reuse these devices can damage the insulative coating or cable resulting in harm to the patient or user.Inspect electrode cables and coated surfaces for possible damage of insulation.The complaint was confirmed and the root cause was associated with component failure.Factors that could have contributed to the reported event include use for a greater time period than anticipated or unintended forces on the handle.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A complaint history review concluded this was an isolated event.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.The two devices were returned together.Both had considerable debris.The glued joints at the cable input had separated on both devices, exposing the internal wiring and compromising the insulation.The complaint was confirmed and the root cause was associated with component failure.Factors that could have contributed to the reported event include use for a greater time period than anticipated or unintended forces on the handle.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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11420745
• Report Number: 3003604053-2021-00068
• Device Sequence Number: 19925906
• Product Code: GEI
• UDI-Device Identifier: 00885554015348
• UDI-Public: 00885554015348
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K041328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2022

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: 08/19/2023
• Device Model Number: 72202213
• Device Catalogue Number: 72202213
• Device Lot Number: 5007354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/02/2021; 03/15/2022
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 04/08/2021; 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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