MAUDE Adverse Event Report: ARTHROCARE CORPORATION WEREWOLF FLOW 50 COBLATION WAND; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	72290037
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a shoulder arthroscopy and rotator cuff repair, the werewolf flow 50 wand was no longer cauterizing as intended.When the wand was withdrawn from the patient's arthroscopic port for inspection, a metal plate that is normally secured to the operative tip was found to be missing.An intraoperative x-ray was obtained before the wound was closed, and the doctor stated, 'we can see our suture anchors, but otherwise, it looks clear to me.'.Further debridement was then performed, followed by bony resection using an arthroscopic burr on the underside of the anterior and lateral acromion to achieve a flat undersurface.At that point, given the significant pathology in the shoulder, it was decided to transition to an open procedure.The settings used in the controller were high.The procedure was completed with a 2-minute surgical delay using a back-up device.There are no issues with the current status of the patient, and no further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection revealed no manufacturing abnormalities.Product was out of the original packaging with no packaging returned, the tip is worn from use and the electrode is missing a portion of its body.A functional evaluation was performed on the returned device and found a wand end of life error.Using a bypass box, the wand was able to produce plasma and activate coag with its remaining electrode.Wand data shows a check electrode notification was produced while in use.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 no similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that all documents provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Based on the information provided the clinical root cause of the reported event could not be determined and we are currently unable to rule out a user technique/ procedural variance as a contributing factor to the reported event.The ifu does caution ¿check the wand tip periodically to ensure the electrode is intact and the wand is functioning as intended¿ and ¿electrode failure and reduced life expectancy may occur if the recommended ablation time for each mode is exceeded.¿ the electrode of the werewolf wand is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.If the non-implantable electrode plate was retained within the patient micro-motion or movement cannot be predicted.There would also be potential risk for tissue inflammation and/or pain.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences.Other factor lines include the device coming into contact with a metal object such as a cannula and mechanical displacement of tissue through applied force.Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.

• Brand Name: WEREWOLF FLOW 50 COBLATION WAND
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22067132
• Report Number: 3006524618-2025-00242
• Device Sequence Number: 9363204
• Product Code: GEI
• UDI-Device Identifier: 00885556617472
• UDI-Public: 885556617472
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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 Catalogue Number: 72290037
• Device Lot Number: 2165780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2024
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male