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

Catalog Number OM-8010

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

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

Event Date 12/01/2017

Event Type  malfunction  

Event Description

It was reported that the hook was not holding the jaw tight enough so it fell off inside the patient.The broken piece was retrieved and the procedure was completed with a back-up device.No injury or other complications occurred.Complaint 2 of 2.See (b)(4) for original report.

Manufacturer Narrative

The reported smartstitch perfectpasser connectors, intended for use in treatment, were 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 evaluation cannot be performed and customers complaint cannot be confirmed.From the information provided, the jaw broke off the device external to patient.An exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) excessive force.Excessive force can result in damage to the device.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; austin, TX 78735
• MDR Report Key: 7094707
• MDR Text Key: 94661430
• Report Number: 3006524618-2017-00400
• 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: 01/29/2018

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: 06/30/2020
• Device Catalogue Number: OM-8010
• Device Lot Number: 2005152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 12/01/2017
• Supplement Dates FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2017
• 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