MAUDE Adverse Event Report: ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF; PASSER

Model Number 22-4038

Device Problem Retraction Problem (1536)

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

Event Date 09/30/2019

Event Type  malfunction  

Event Description

It was reported that during the procedure the surgeon was able to fire the needle using the triggers, but the needle did not return to the initial position.No patient injuries or delay reported.Back-up device was not available.

Manufacturer Narrative

The returned device used in treatment, was returned for evaluation.There was no relationship found between the returned device and the reported incident.A review of the device history records for the reported lot number 2023580 showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review for lot number 2023580 for the past 3 years found no related failures.Visual inspection shows a device which was returned deployed.The instrument was returned with an opened bracket.There were no manufacturing abnormalities found on the device.Functional evaluation revealed that the two step trigger performed as intended.The bracket could be opened /closed as specified.The needle could be extended without any issues.The complaint was not verified as the device performed as intended during the test.The root cause could not be determined with certainty as the device performed as intended.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: (1) improper handling of the two step trigger (2) the bracket get caught on tissue (3) the bracket got sticky during the surgery there were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.No containment or corrective actions are recommended at this time.

• Brand Name: DISP FIRSTPASS STR PASSR SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9189226
• MDR Text Key: 167662467
• Report Number: 3006524618-2019-00507
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2021
• Device Model Number: 22-4038
• Device Catalogue Number: 22-4038
• Device Lot Number: 2023580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1