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 10/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during a procedure, the firstpass' upper jaw broke inside the patient's incision.The broken piece was removed from within the patient.There was a backup device available.A 5 minute delay and no further 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 reported device, used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.A review of the device history records for the reported lot number 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 repeated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found that excessive force can result in device damage.Visual evaluation shows the suture trap is missing.Functional test was performed on the returned device using suture and foam to replicate the tissue.Lever actuation was smooth and the needle was able to penetrate thru the foam and pass a stitch.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: 10875355
• MDR Text Key: 217329219
• Report Number: 3006524618-2020-01013
• 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: 12/26/2020

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: 10/30/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 12/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention