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

Catalog Number OM-8010

Device Problems Detachment Of Device Component (1104); Failure to Fire (2610)

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

Event Date 09/13/2017

Event Type  malfunction  

Event Description

It was reported that the perfect passer connector was loaded onto the smartstitch handle and when attempting to fire, the jaw disengaged from the device and had to be retrieved from the patient.The procedure was completed using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

The reported perfectpasser connectors, intended for use in treatment, were returned for evaluation.A relationship between the devices and reported incident was established.From the information provided, jaws disengaged from the device.Visual inspection shows the connectors were received with the s-clamp unhooked from the s-hook.One of the connectors was returned without the s-clamp.Internal investigation indicates the failure cause for upper s-clamp coming loose is due to a dimensional discrepancy on the s-hook component.The instruction for use (ifu) were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that the perfectpasser connector was loaded onto the smartstitch handle and when attempting to fire, the jaw disengaged from the device and had to be retrieved from the patient.The procedure was completed using a back-up device.No patient injury or other complications were reported.Complaint 1 of 3.See (b)(4) for 2nd and 3rd devices.Additional devices received 10/18/2017.

• 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: 6904357
• MDR Text Key: 88032585
• Report Number: 3006524618-2017-00297
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

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: 1178577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: 11/07/2017
• Supplement Dates FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1