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

Catalog Number 22-4038

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/10/2018

Event Type  malfunction  

Event Description

It was reported that the teeth from top jaw broke off in 2 pieces and fell into patient.All pieces were removed from patient.There was a surgical delay greater than 30 minutes and a backup device was available to complete the procedure with no patient injuries.

Manufacturer Narrative

The reported disposable firstpass suture passer, intended for use in treatment, was returned for evaluation.A relationship between the device and reported incident was established based on our visual observations.From the information provided, the teeth from top jaw broke off in 2 pieces and fell into patient.Visual evaluation shows the suture trap is broken off and the pieces have been returned.No other visual discrepancies.During functional evaluation the two step trigger performed as intended.The needle passed the suture through a piece of foam by using the index finger and depressing the trigger.Based on visual observations, customer¿s complaint was confirmed.An exact root cause cannot be determined with confidence; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: excessive force.Incorrect suture used during the case.Insufficient retention of suture capture.Excessive force applied to the product or incorrect clinical suture used can result in product failure or damage to the product.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 CORPORATION; 7000 west william cannon drive; austin TX 78735
• MDR Report Key: 7879104
• MDR Text Key: 120526615
• Report Number: 3006524618-2018-00474
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22-4038
• Device Lot Number: 2015805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1