MAUDE Adverse Event Report: ARTHROCARE CORPORATION FIRSTPASS MINI STRAIGHT; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72290128

Device Problems Unstable (1667); Material Deformation (2976)

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

Event Date 01/24/2024

Event Type  malfunction  

Event Description

It was reported that during an arthroscopy, when the tissue was punctured with the firstpass, the catch mechanism came loose, nothing remained in the patient.The procedure was completed with a s+n back up device.There was a delay less than 30 minutes and no further complications were reported.

Manufacturer Narrative

Internal complaint reference case (b)(4).

Manufacturer Narrative

H6 codes (medical device problem code) updated.H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned with any original packaging.The suture capture has been disconnected from the upper jaw and is deformed.Bio debris is present.No other visual deficiencies.A functional evaluation showed pulling the lever will close the jaw and deploy the suture passer needle.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.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.An analysis of the customer provided images found that the suture capture looks displaced from its normal position.The root cause was associated with unintended use of the device.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 STRAIGHT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18712734
• MDR Text Key: 336321727
• Report Number: 3006524618-2024-00068
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556694558
• UDI-Public: 00885556694558
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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 Catalogue Number: 72290128
• Device Lot Number: 2116614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female