MAUDE Adverse Event Report: ARTHROCARE CORPORATION FIRSTPASS SUTURE PASSER; SUTURE UNITS

Catalog Number 22-4035R

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2015

Event Type  malfunction  

Event Description

It was reported that during a shoulder procedure using a firstpass suture passer, the jaws on the device were not closing properly preventing tissue from being grabbed.The surgeon opted to complete the procedure using a competitive device.There were no significant delays or pt complications reported as a result of this event.

Manufacturer Narrative

The returned firstpass handle was received with the upper jaw severely sprained and the right handle is broken on the top corner close to the screw.The suture capture is stuck on the upper jaw and is slightly bent.Functional testing could not be performed due to the damaged condition.Based on our investigation the most plausible root cause for the failure could be incorrect suture capture removal technique.The ifu states "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" and "as with any surgical instrument, care should be taken to ensure that excessive force is not placed on these devices, otherwise, failure may result".

• Brand Name: FIRSTPASS SUTURE PASSER
• Type of Device: SUTURE UNITS
• 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; austin, TX 78735 ; 5123585933
• MDR Report Key: 4768638
• MDR Text Key: 5792435
• Report Number: 3006524618-2015-00081
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 22-4035R
• Device Lot Number: 2336R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1