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

Model Number OM-8010

Device Problem Detachment Of Device Component (1104)

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

Event Date 11/20/2017

Event Type  malfunction  

Event Description

It was reported that the device top jaw came off inside the shoulder joint.Top jaw was retrieved from the patient, no injuries were reported.Procedure was completed with a backup device.

Manufacturer Narrative

The returned device, intended for use in treatment, was returned for evaluation.There was a relationship found between the device and the reported incident.Visual inspection shows a broken/detached grasper at distal end.The grasper was not returned for further evaluation.During the functional evaluation both needles could be extracted by using a smart stitch device.The rod inside the pp-connector doesn't move when the clamp lever is pressed.The complaint was verified.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 drive
• MDR Report Key: 7079567
• MDR Text Key: 93883442
• Report Number: 3006524618-2017-00387
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00817470006971
• UDI-Public: (01)00817470006971(17)200229(10)1184075
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• 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: 02/29/2020
• Device Model Number: OM-8010
• Device Catalogue Number: OM-8010
• Device Lot Number: 1184075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/04/2017
• Supplement Dates Manufacturer Received: 01/19/2018
• Supplement Dates FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1