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

Catalog Number OM-8010

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2018

Event Type  malfunction  

Event Description

It was reported that the jaw came off and dislodged inside the patient.The broken piece was removed and the procedure was completed using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

The reported smartstitch pp connector, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual and functional evaluation cannot be performed and customers complaint cannot be confirmed.From the information provided, the top jaw is falling off.An exact root cause cannot be determined with confidence; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: excessive force.Excessive force applied to the device can result in damage to the device and device failure.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 7232970
• MDR Text Key: 98887917
• Report Number: 3006524618-2018-00055
• 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: 03/07/2018

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 Expiration Date: 07/31/2020
• Device Catalogue Number: OM-8010
• Device Lot Number: 2006014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 01/09/2018
• Supplement Dates FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• 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