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

Catalog Number 72290128

Device Problem Failure to Advance (2524)

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

Event Date 10/24/2018

Event Type  malfunction  

Event Description

It was reported that the handle was squeezed for several times through the tissue but it failed to pass a suture.During a re-introduce, the needle breaks.The broken piece was located and removed.A backup device was available to complete the procedure with no significant delay and no patient injuries.

Manufacturer Narrative

There was a relationship found between the returned device and the reported incident.Visual inspection shows a broken jaw on the tip of the instrument.The needle was broken as well.The broken parts were not received.There are no manufacturing abnormalities visible on the returned instrument.The returned firstpass mini straight is a single used device and can only be limited functional tested.The remaining part of the jaw was tested and could be sloped extended.The handle was tested and performed as intended.The complaint was verified but the root cause could not be determined with certainty.Potential factors that could contribute the reported event are (1) improper suture loading, (2) excessive tensioning or (3) improper alignment of the inserter handle.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 CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8061884
• MDR Text Key: 127075397
• Report Number: 3006524618-2018-00588
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556694558
• UDI-Public: 00885556694558
• 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: 01/10/2019

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
• Device Lot Number: 2016135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1