MAUDE Adverse Event Report: ARTHROCARE CORPORATION FIRSTPASS MINI STRAIGHT; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72290128

Device Problem Device Fell (4014)

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

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that trap in the top jaw fell out.It fell out of the jaw completely.The surgeon stated he saw a bit of metal outside the joint, however it could not be found when searched through all the suction pots and sterile drapes.No surgical delay or patient injury 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 returned device and the reported incident.Visual inspection of the instrument show no manufacturing abnormalities.The front draw indicates a detached trap.The part was not returned with the device.The returned firstpass mini straight is a single used device and can only be limited functional tested.The needle was deployed into a dome foam model (om-3003) and performed as specified; however the trap at distal end is missing.The instrument is damaged and will not work any more as intended.The complaint was verified but the root cause could not be determined with certainty.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: FIRSTPASS MINI STRAIGHT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• MDR Report Key: 7820171
• MDR Text Key: 118532488
• Report Number: 3006524618-2018-00434
• Device Sequence Number: 1
• Product Code: NBH
• 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: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72290128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 10/22/2018
• Supplement Dates FDA Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1