MAUDE Adverse Event Report: ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF; PASSER

Catalog Number 22-4038

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during a shoulder arthroscopy and a rotator cuff repair, the thread catcher of firstpass suture passer detached from the upper jaw.It was removed by an arthroscopic grasping forceps.The procedure was completed without significant delay using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: DISP FIRSTPASS STR PASSR SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 12291564
• MDR Text Key: 265566255
• Report Number: 3006524618-2021-00813
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00885556724545
• UDI-Public: 885556724545
• 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: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2023
• Device Catalogue Number: 22-4038
• Device Lot Number: 2056899
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention