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

Catalog Number 22-4038

Device Problem Difficult to Open or Close (2921)

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

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that during an arcr procedure, when rotator cuff suturing, the tip of jaw could not open.Both handle and needle could not open.Back-up device was used.No patient injury, but 40 minutes delay was reported.

Manufacturer Narrative

The returned device, intended for use in treatment, was returned as an mdr for evaluation.There was no relationship found between the device and the reported incident.Visual inspection shows a device which was returned deployed.The instrument was returned with an open bracket.There were no manufacturing abnormalities found on the device.During functional evaluation the two step trigger performed as intended.The bracket could be closed/opened as specified.The needle deploy through a om-3003 dome foam model by using the index finger and depressing the trigger.The self-capture is working as intended and the ultratape (cobraid blue 38¿)was successfully passed through as intended.The complaint was not verified and the root cause could not be defined with certainty.Factors unrelated to the design and manufacture of the device which could have contributed to the complaint event are (1) excessive force is be applied to the device when manipulating soft tissue, bone, or hard objects.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 8081335
• MDR Text Key: 127622274
• Report Number: 3006524618-2018-00603
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22-4038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Date Manufacturer Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1