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

Catalog Number 23-2005

Device Problem Break (1069)

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

Event Date 11/13/2017

Event Type  malfunction  

Event Description

It was reported that the tip broke on two devices (from the same lot) while passing through the tissue.The broken pieces were removed and the procedure was completed with a back-up device without further complications.Complaint 1 of 2.See (b)(4) for 2nd device.

Manufacturer Narrative

There was a relationship found between the returned device and the reported event.Visual inspection for the device revealed the needle crescent broke off.No other visual discrepancies were found.Functional evaluation was not performed due to the broken condition of the returned device.Per information provided by the customer, the tip broke while passing through the tissue.Based on our visual investigation the reported event was confirmed; however, the root cause cannot be determined with confident.Factors unrelated to the manufacturing or design of the device that could have contributed to the reported event includes: as with any surgical instrument, careful attention should be made to assure that excessive force is not placed on this instrument.Excessive force can result in failure.Tissue thickness may affect suture placement including stitch depth and needle entry point.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 devices did not meet product specifications upon release into distribution.Device returned for evaluation.Device evaluated by the manufacturer.

• 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: 7038708
• MDR Text Key: 93140421
• Report Number: 3006524618-2017-00367
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• 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: 1174558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1