MAUDE Adverse Event Report: ARTHROCARE CORPORATION FIRSTPASS NEEDLE AND SUTURE CAPTURE; NEEDLES, SUTURE

Catalog Number 22-4036

Device Problem Positioning Problem (3009)

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

Event Date 05/06/2014

Event Type  malfunction  

Event Description

It was reported that during a shoulder procedure using a firstpass needle and suture capture, the needle was not loading into the handle properly.The surgeon opted to complete the procedure using a competitor's device.There were no significant delays or pt complications reported as a result of this event.

• Brand Name: FIRSTPASS NEEDLE AND SUTURE CAPTURE
• Type of Device: NEEDLES, SUTURE
• Manufacturer (Section D): ARTHROCARE CORPORATION; austin TX
• Manufacturer (Section G): ARTHROCARE COSTA RICA; la aurora, heredia ; CS
• Manufacturer Contact: wendy laird ; 7000 w william cannon dr., bldg 1; building one; austin, TX 78735 ; 5123585933
• MDR Report Key: 3915473
• MDR Text Key: 15114684
• Report Number: 3006524618-2014-00161
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2014

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: 11/01/2015
• Device Catalogue Number: 22-4036
• Device Lot Number: 1030630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2014
• Initial Date FDA Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2012
• 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
• Patient Outcome(s): Other