MAUDE Adverse Event Report: ARTHROCARE CORP. FIRSTPASS SUTURE PASSER

Model Number 22-4035

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 01/27/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a shoulder arthroscopy using the 'firstpass suture passer', the trap door came off when loading the needle on back table.Used a second needle and trapdoor kit and was successfully loaded on back table.When surgeon went to pass suture through the rotator cuff, the trap door came dislodged.The free floating trap door was removed using a cuff grasper.The procedure was completed with a non-significant delay using a smith and nephew backup device.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).H10 h3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A visual evaluation showed the device did not have a suture capture or needle when returned.No deficiencies are visible.A functional evaluation showed the test needle and suture capture were loaded into the device.Pulling the trigger to the first stop closed and locked the jaw.Pulling the trigger to the second stop, deployed the needle, which caught the test suture and captured it.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 found no similar reported events.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 risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Based on the information provided, the free-floating trap door was removed from inside of the patient with a cuff grasper.Since there were no other complications reported, no further clinical/medical assessment is warranted at this time.Should any additional relevant patient information be provided, this case would be re-assessed.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

Event Description

It was reported that, during a shoulder arthroscopy using the 'firstpass suture passer', the trap door came off when loading the needle on back table.Used a second needle and trapdoor kit and was successfully loaded on back table.When surgeon went to pass suture through the rotator cuff, the trap door came dislodged.The free floating trap door was removed using a cuff grasper.The procedure was completed with a non-significant delay using a smith and nephew backup device.No further complications were reported.Patient current status is fine.

• Brand Name: FIRSTPASS SUTURE PASSER
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13549204
• MDR Text Key: 285744862
• Report Number: 3006524618-2022-00060
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00817470000160
• UDI-Public: 00817470000160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

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 Model Number: 22-4035
• Device Catalogue Number: 22-4035
• Device Lot Number: K5001FC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 02/02/2022
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention