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

Model Number 72290130

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event Description

It was reported that during a knee meniscus root repair, the first pass mini tape passed successfully the first time through the meniscus but the second tape failed to capture suture 5 times.The procedure was completed with a backup device and no delay or further complications 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 reported device used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection of the returned device shows suture trap is broken.A functional evaluation shows the needle will deploy when trigger is initiated.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness (3) damage or debris on the device tip between passes.No containment or corrective actions are recommended at this time.

• Brand Name: FIRSTPASS MINI RIGHT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10979654
• MDR Text Key: 220653187
• Report Number: 3006524618-2020-01082
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556694572
• UDI-Public: 00885556694572
• Combination Product (y/n): N
• 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: 04/07/2021

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 Expiration Date: 03/11/2022
• Device Model Number: 72290130
• Device Catalogue Number: 72290130
• Device Lot Number: 2030309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1