MAUDE Adverse Event Report: ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF; PASSER

Catalog Number 22-4038

Device Problem Mechanical Jam (2983)

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

Event Date 02/27/2018

Event Type  malfunction  

Event Description

It was reported that the jaw locked closed on two devices during use.The procedure was completed with a competitive device.No patient injury or other complications were reported.

Manufacturer Narrative

The reported disposable firstpass suture passer device, intended for use in treatment, was returned for evaluation.A relationship between the device and reported incident was established based on our visual and functional evaluations.Visual evaluation of the returned device shows the pinion gear was found out of position.Device was received with its lever in acceptable working condition; however, upon opening the device, the pinion gear was found out of position.Functional test was performed and the device was able to function as intended.Ultratape suture and foam to replicate tissue were used to test the device.Suture was able to load and lever was able to actuate and pass the needle thru foam.Suture was passed and captured as intended.Based on visual and functional observations, customers complaint was confirmed.Root cause based on further evaluation is due to insufficient manufacturing specification.Changes have been implemented to eliminate or reduce the failure from happening again.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: DISP FIRSTPASS STR PASSR SELF
• Type of Device: PASSER
• 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: jim gonzales ; 7000 w. william cannon dr.; austin, TX 78735
• MDR Report Key: 7358791
• MDR Text Key: 103413615
• Report Number: 3006524618-2018-00139
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00817470012309
• UDI-Public: (01)00817470012309(17)201130(10)2008643
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22-4038
• Device Lot Number: 2008643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1