MAUDE Adverse Event Report: ARTHROCARE CORPORATION WEREWOLF FASTSEAL 6.0; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	72290042
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during a hip procedure, the werewolf fastseal would turn on and not turn off.Surgery was completed with a back-up device instead.There was a surgical delay of less than 30 minutes, and no further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection revealed no manufacturing abnormalities, the tip is worn from use, and product was out of the original packaging with no packaging returned.A functional evaluation was performed on the returned device and found a wand end of life error.Using a bypass box, the wand had no issues activating coag.The button did not get stuck nor did the device stay turned on.The button cover was removed and found no issues.Wand data shows the wand experienced a multiple button press warning.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include saline/humidity entered the interior of the handle shorting the connection of the buttons.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: WEREWOLF FASTSEAL 6.0
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20163942
• Report Number: 3006524618-2024-00370
• Device Sequence Number: 7235472
• Product Code: GEI
• UDI-Device Identifier: 00885556787229
• UDI-Public: 885556787229
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K210423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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 Catalogue Number: 72290042
• Device Lot Number: 2148268
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2024
• 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