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

Catalog Number 22-4036

Device Problem Failure to Advance (2524)

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

Event Date 02/19/2019

Event Type  malfunction  

Event Description

It was reported that while using a graft jacket, the doctor went to pass the needle through and it got caught in the tissue.The needle did not puncture the graft, was pushed through the self capture door by the needle and the graft was then caught in the door.The procedure was successfully completed without delay, a back-up device from a competitor was used.No patient injury or other complications were reported.

Manufacturer Narrative

The reported needle and suture capture, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.From the information provided, ¿while using a graft jacket, the doctor went to pass the needle through and it got caught in the tissue.The needle did not puncture the graft, was pushed through the self capture door by the needle and the graft was then caught in the door.¿ an exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) incorrect needle and suture trap loading.(2) excessive force.Prior to use examine the instrument and check for proper functioning.This instrumentation is designed for use by surgeons experienced in the appropriate specialized procedures.It is the responsibility of the surgeon to become familiar with the proper techniques.As with any surgical instrument, care should be taken to ensure that excessive force is not placed on these devices, otherwise, failure may result.The needle and trap must be inserted to the proper depth and orientation in order to permit the firstpass suture passer to function properly.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: FIRSTPASS
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8368558
• MDR Text Key: 137542202
• Report Number: 3006524618-2019-00114
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00817470000184
• UDI-Public: 00817470000184
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

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 Expiration Date: 03/31/2020
• Device Catalogue Number: 22-4036
• Device Lot Number: 1189151
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 04/22/2019
• Supplement Dates FDA Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1