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 12/12/2016

Event Type  malfunction  

Event Description

It was reported that the suture passer needle bent then broke while passing suture during an acetabular labrum reconstruction.The device was able to be withdrawn from the surgical site without the needle becoming completely detached.Another suture passer was utilized and again, the needle bent while passing the second suture.The surgeon opted to complete the procedure using a conventional suture passing technique.No patient injury or other complications were reported.Complaint 2 of 2 (reference (b)(4) for 1st failed device).

Manufacturer Narrative

The returned accu-pass devices were received with their needles broken near the distal end of the outer tube.Per information provided, needle bent then broke while passing suture.The complaint was confirmed as the needles were received broken.An exact root cause could not be determined with confidence however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: tissue thickness which may have required excessive load on the needle.Tissue thickness may affect the needle penetration by requiring excessive load to be placed on the needle.The instruction for use (ifu) were reviewed and found to include precautionary statements and instructions regarding the use of the device to avoid damage or non-functionality.There were no indications during manufacturing record review that would suggest 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; austin, TX 78735 ; 5123585706
• MDR Report Key: 6231902
• MDR Text Key: 64581771
• Report Number: 3006524618-2017-00012
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2017
• 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: 1153290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer 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
• Patient Age: 20 YR