MAUDE Adverse Event Report: ARTHROCARE CORP. 2.3MM SHORT BEVEL 35 DEGREE ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AC2823-01
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during waist surgery, the wand was unable to plug into quantum consoles: it was broken.When the surgeon tried to plug in, it bent the pins inside and did not match up with console.The procedure was completed with a competitor device with no significant delay.No other complications were reported.
Additional Manufacturer Narrative
H10 h3,h6: the device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.A review of the device history 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 found no related failures.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.Risk management documents review found no additional risks that require to be added to the reference document.Visual inspection and functional testing could not be performed since the device was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: (1) misalignment or connecting the wand to the unintended port which could have caused damage to the pin.There are no indications to suggest the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: 2.3MM SHORT BEVEL 35 DEGREE ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10341866
• Report Number: 3006524618-2020-00556
• Device Sequence Number: 3484897
• Product Code: GEI
• UDI-Device Identifier: 00817470004564
• UDI-Public: 00817470004564
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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 Model Number: AC2823-01
• Device Catalogue Number: AC2823-01
• Device Lot Number: 2046992
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention