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

Catalog Number 72290130

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/08/2019

Event Type  malfunction  

Event Description

It was reported that, during a peripheral radial meniscal repair, the one door of the firstpass mini right top jaw broke off with the needle extended.After unsuccessful attempts to remove the piece using an arthroscopic grasper, the piece was deemed unretrievable.A s&n back-up device was used to successfully complete the procedure.The surgery was delayed for more than half-an-hour.It was not stated that the patient suffered an adverse event as consequence of the alleged malfunction.

Manufacturer Narrative

The reported firstpass mini right device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.From the information provided, ¿during a peripheral radial meniscal repair, the one door of the firstpass mini right top jaw broke off with the needle extended.¿ an exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) excessive force.(2) tissue thickness.

Manufacturer Narrative

H10/h11: the initial incident report was submitted with incorrect manufacturing site information and registration number 1219602 (s+n mansfield).The correct manufacturing site information and registration number is 3006524618 (s+n austin).

• 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: 8561035
• MDR Text Key: 143541477
• Report Number: 1219602-2019-00475
• Device Sequence Number: 1
• Product Code: NBH
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2020

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 Expiration Date: 12/11/2021
• Device Catalogue Number: 72290130
• Device Lot Number: 2021048
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 06/11/2019; 06/11/2019
• Supplement Dates FDA Received: 06/12/2019; 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR