MAUDE Adverse Event Report: ARTHROCARE CORP. ACCU-PASS DIRECT CRESCENT XL; PASSER

Catalog Number 23-2005

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/02/2017

Event Type  malfunction  

Event Description

It was reported that while using #2 vicryl to shuttle #2 ultrabraid suture with the accupass, during the first pass, the vicryl was not completely ejecting from the mouth of the passer.During the second attempt, the surgeon shook the passer and extended it further into the joint in order to completely eject the vicryl.On the third attempt, the vicryl could not be ejected at all and the passer had to be pulled out of the joint to free it manually.The procedure was completed using a competitive device (stryker nano pass).

Manufacturer Narrative

Correct date received by manufacturer: 12/27/2017.

Manufacturer Narrative

The reported accu-pass direct crescent xl device was used for treatment.The device was received for evaluation.A relationship between the device and reported incident was established.Visual inspection revealed no cosmetic or physical abnormality with the returned device.Functional test cannot be performed due to the accu-pass is a single use device.Per information provided customer used #2 vicryl to shuttle #2 ultrabraid suture with the accupass.The most potential root cause for the failure coud be off label/abnormal use.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: this device is qualified for use with magnumwire and ultrabraid sutures (usp #2/metric size 5).There were no indications that would suggest that the device did not meet product specifications upon release into distribution.This is a single use device and it was the initial use of the device.

• Brand Name: ACCU-PASS DIRECT CRESCENT XL
• Type of Device: PASSER
• 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: 7023205
• MDR Text Key: 92801612
• Report Number: 3006524618-2017-00357
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 23-2005
• Device Lot Number: 1174558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2016
• 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