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

Model Number 72290128

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 10/23/2020

Event Type  Injury  

Event Description

It was reported that during a procedure, the upper jaw of the firstpass mini straight broke and felt inside the patient.The piece was removed from the patient.The procedure was completed without significant delay (3 minutes) using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h2, h3, h6.The device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A review of risk management files found that the reported failure was documented appropriately.A complaint history review concluded this was an isolated event.A review of the instructions for use found statements and precautions regarding device handling.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness.(3) damage or debris in the device tip between passes.There were no indications 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: 10825537
• MDR Text Key: 215975616
• Report Number: 3006524618-2020-00983
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2023
• Device Model Number: 72290128
• Device Catalogue Number: 72290128
• Device Lot Number: 2046648
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention