MAUDE Adverse Event Report: ARTHROCARE CORP. SMARTSTITCH PP CONNECTOR; ACCESSORIES,ARTHROSCOPIC

Catalog Number OM-8010

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

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

Event Date 01/18/2018

Event Type  malfunction  

Event Description

It was reported that the self capture device failed and dislodged from the tip of two devices from the lot 2005153 and device from lot 1192014.The broken pieces were removed and the procedure was completed using a back-up device.No patient injury or other complications were reported.Complaint 3 of 3.See (b)(4) for related complaints.

Manufacturer Narrative

The reported perfect passer connector, intended for use in treatment, was returned for evaluation.A relationship between the device and reported incident was established.From the information provided, the device failed and dislodged from the tip.Visual inspection shows the connector was received with the s-clamp unhooked from the s-hook and the s-clamp was not returned.Internal investigation indicates the failure cause for upper s-clamp coming loose is due to a dimensional discrepancy on the s-hook component.Changes to the component have been implemented to prevent this failure.

• Brand Name: SMARTSTITCH PP CONNECTOR
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: 7250579
• MDR Text Key: 99946952
• Report Number: 3006524618-2018-00069
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

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 Catalogue Number: OM-8010
• Device Lot Number: 1192014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 03/05/2018
• Supplement Dates FDA Received: 03/06/2018
• 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