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

Catalog Number OM-8010

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 01/04/2018

Event Type  malfunction  

Event Description

It was reported that the jaw broke off at the joint.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 perfectpasser 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 jaw broke off at the joint.Visual inspection shows the connector was received with its s-clamp unhooked from the s-hook.The clamp was not broken as indicated by the customer; however, it did come loose.Internal investigation indicates the failure cause for upper s-clamp unhooked is due to a dimensional discrepancy on the s-hook component.Changes to the component have been implemented to prevent this failure.The instruction for use (ifu) was reviewed and was 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 that would suggest that the device did not meet product specifications upon release into distribution.Device returned for evaluation.Device evaluated by the manufacturer.

• 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: 7173551
• MDR Text Key: 96813801
• Report Number: 3006524618-2018-00023
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

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: 1194208
• 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: 01/04/2018
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 02/01/2018
• 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