MAUDE Adverse Event Report: ARTHROCARE CORP. ACCU-PASS DIRECT CRESCENT XL; ACCESSORIES,ARTHROSCOPIC

Catalog Number 23-2005

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2016

Event Type  malfunction  

Event Description

It was reported that during a procedure using an accu-pass direct crescent xl, the surgeon tried to insert into a 3.0 outflow cannula against suggested use, causing the device to bend.The procedure was completed using a competitive device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

The reported accu-pass direct crescent xl device was used for treatment of a labral repair.The device was received for evaluation.A relationship between the device and reported incident was established.The reported device was received and its distal end was found broken.Needle crescent broke off (not returned) and left the tumble flat wire exposed.Functional test cannot be performed as the accu-pass device is a single use device.Per information provided, the surgeon tried to insert into a 3.0 outflow cannula against the representative's advice and by the time the surgeon got to the tissue and attempted to try and insert it, the device bent.The surgeon was able to pull the device out.Based on complaint information and our visual inspection, the needle broke off due to passing thru a smaller cannula.Passing the device thru a smaller cannula can add additional force to pass thru forcing the device to bend and break.Instructions for use were reviewed and the cannula size, if used, should be a minimum of 5.0mm.Customers complaint was confirmed and root cause based on our visual inspection and complaint information is due to abnormal use.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: (1) incorrect cannula used.The instruction for use (ifu) outlines 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.

• Brand Name: ACCU-PASS DIRECT CRESCENT XL
• 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 dr.; austin, TX 78735 ; 5123585706
• MDR Report Key: 5994170
• MDR Text Key: 56807777
• Report Number: 3006524618-2016-00264
• Device Sequence Number: 1
• Product Code: NBH
• 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
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2016

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: 23-2005
• Device Lot Number: 1144234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 10/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2016
• 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