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

Catalog Number 23-2005

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

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

Event Date 11/25/2016

Event Type  malfunction  

Event Description

It was reported that the tip of the device broke off when the surgeon was pushing the instrument through tissue.Unable to confirm whether the broken piece was retrieved or left in situ.However, no patient injury or other complications have been reported.

Manufacturer Narrative

Additional/corrected: the returned accu-pass device was received with its needle broken near the distal end of the outer tube.Blue cobraid magnumwire was received captured by the needle.Needle and outer tube crimp was present.Per information provided, the tip of the accupass broke off when the surgeon was pushing the instrument through tissue.Based on our visual evaluation, the complaint was confirmed as the needle was received broken.An exact root cause could not be determined with confidence.A potential factor unrelated to the manufacture or design of the device that could have contributed to the reported event includes tissue thickness.Tissue thickness may affect suture placement including stitch depth and needle entry point.The instruction for use (ifu) were reviewed and 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 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: 6191217
• MDR Text Key: 63233343
• Report Number: 3006524618-2016-00347
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

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: 1153290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2017
• 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