MAUDE Adverse Event Report: ARTHROCARE CORP. TOPAZ MICRODEBRIDER ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	Q6000-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/01/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on literature review "fascial incision and adhesiolysis combined with radiofrequency microtenotomy in treatment of chronic midportion achilles tendinopathy", 1 patient had a deep venous thrombosis after a fascial incision and adhesiolysis combined with radiofrequency microtenotomy procedure using a topaz microdebrider icw wand.The event was treated with anticoagulants.No further information is available.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.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.A clinical review states per the complaint details, a study patient (sited from a literature review) ¿1 patient had a deep vein thrombosis¿ after a fascial incision and adhesiolysis combined with radiofrequency microtenotomy procedure.¿ smith and nephew has not received the device and/or adequate documentation to fully evaluate the root cause of the reported event.Therefore, the root cause of the reported deep vein thrombosis and/or the patient outcome beyond that which was documented in the aged article cannot be confirmed nor concluded.No further medical assessment is warranted at this time.Should additional information/documentation become available, the clinical/medical task may be re-opened for further evaluation.There was no relationship found between the device and the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include a failure of a concomitant device.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: TOPAZ MICRODEBRIDER ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14541316
• Report Number: 3006524618-2022-00259
• Device Sequence Number: 15147226
• Product Code: GEI
• UDI-Device Identifier: 00817470004380
• UDI-Public: 817470004380
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K080282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: Q6000-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 05/30/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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