MAUDE Adverse Event Report: ARTHROCARE CORP. 2.5MM 90 DEGREE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	A1325-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee surgery the top of the wand broke off.No patient injuries or delay reported.Back-up device was available to complete the surgery.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 device, used in treatment, was not returned for evaluation.A relationship between the reported event and the device could not be established.A review of the device history records for the reported lot number 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 for lot number for the past 3 years found no related failures.Without the reported product a visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.Potential factors unrelated to the design or manufacture of the device that may lead to broken tip include, but are not limited to: this wand is designed for ablation and/or coagulation only, and not for mechanical displacement of tissue through applied force.This may result in bent or detached electrodes, damage to device and/or cracked spacer.Do not use the wand as a lever to enlarge surgical site or gain access to tissue, which may result in bent or detached electrodes, damage to device and/or cracked spacer.There are no indications to suggest that the device/product did not meet specifications upon release into distribution.

• Brand Name: 2.5MM 90 DEGREE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9285717
• Report Number: 3006524618-2019-00540
• Device Sequence Number: 150909
• Product Code: GEI
• UDI-Device Identifier: 00817470000030
• UDI-Public: 00817470000030
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K011083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 11/23/2020
• Device Model Number: A1325-01
• Device Catalogue Number: A1325-01
• Device Lot Number: 2024206
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1