MAUDE Adverse Event Report: ARTHROCARE CORP. FIRSTPASS MINI RIGHT; ACCESSORIES,ARTHROSCOPIC

Model Number 72290130

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2020

Event Type  malfunction  

Event Description

It was reported that during knee surgery, the firstpass mini right was not capturing the sutures.A backup device was available to complete the procedure with no delay or patient injuries.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

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 for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.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.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: FIRSTPASS MINI RIGHT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10590355
• MDR Text Key: 208746327
• Report Number: 3006524618-2020-00821
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556694572
• UDI-Public: 00885556694572
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

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
• Device Operator: Health Professional
• Device Model Number: 72290130
• Device Catalogue Number: 72290130
• Device Lot Number: 2030310
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1