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

Model Number 72290128

Device Problem Break (1069)

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

Event Date 09/28/2020

Event Type  malfunction  

Event Description

It was reported that during a surgery the top jaw of the firstpass mini suture passer broke off outside the patient.The procedure was successfully completed without a significant delay 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

H3, h6: the device, used in treatment, was not returned for evaluation.There was a relationship found between the device and the reported incident, as an image of the device was submitted by the customer.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 complaint history review concluded this was a repeat issue.The image provided by the customer showed the device's top jaw was broken off.Inspection of the customer provided image revealed that the device's electrodes were detached; however, it could not be deduced if it was worn or missing completely.Visual inspection and functional testing could not be performed since the device was not returned for evaluation; however, the complaint was confirmed as the submitted image provided sufficient evidence to confirm.The complaint was confirmed.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: (1) excessive force (2) device used as a lever for manipulating hard tissue or bone there are no indications to suggest the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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: 10712528
• MDR Text Key: 212321587
• Report Number: 3006524618-2020-00899
• 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: 11/25/2020

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 Model Number: 72290128
• Device Catalogue Number: 72290128
• Device Lot Number: 2047493
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1