MAUDE Adverse Event Report: ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 22-4038

Device Problems Sticking (1597); Difficult to Open or Close (2921)

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

Event Date 06/27/2016

Event Type  malfunction  

Event Description

It was reported that during a procedure using a firstpass suture passer, the device became stuck closed and would not re-open.The procedure was completed using a competitive device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Visual inspection and functional evaluation of the product could not be performed because the device was not returned for investigation.Per information provided, the device was stuck closed and would not reopen.The customer¿s complaint could not be verified, nor could a root cause be determined with confidence.However, factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: tissue thickness may affect suture placement including stitch depth and needle entry point.A surgeon should not begin clinical use of the device without reviewing the instructions for use and practicing the procedure in a skills laboratory.The instruction for use (ifu) outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.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: DISP FIRSTPASS STR PASSR SELF
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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; austin, TX 78735
• MDR Report Key: 5871967
• MDR Text Key: 52788156
• Report Number: 3006524618-2016-00200
• Device Sequence Number: 1
• Product Code: MBI
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• 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: 1132151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2016
• 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