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

Catalog Number 22-4038

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/28/2018

Event Type  malfunction  

Event Description

It was reported that during arcr procedure, part of tooth broke.The broken piece was retrieved from the patient.No patient injury was reported.Five minutes delay was reported.

Manufacturer Narrative

The returned device, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship found between the device and the reported incident.Visual inspection shows a device which was returned with an open bracket.The self-capture was received seperately.There were no manufacturing abnormalities found on the device.During functional evaluation the two step trigger performed as intended.The needle deploy through a om-3003 dome foam modelby using the index finger and depressing the trigger, however the self-capture part is missing.The complaint was verified and the root cause could not be determined with certainty.Excessive force should not 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 CORPORATION; 7000 west william cannon drive; austin TX 78735
• MDR Report Key: 7722710
• MDR Text Key: 115535522
• Report Number: 3006524618-2018-00388
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00817470012309
• UDI-Public: (01)00817470012309(17)201123(10)2008136
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2020
• Device Catalogue Number: 22-4038
• Device Lot Number: 2008136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Date Manufacturer Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1