MAUDE Adverse Event Report: ARTHROCARE CORPORATION FIRSTPASS SUTURE PASSER

Catalog Number 22-4035

Device Problems Break (1069); Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during a shoulder arthroscopy, when assembling the clamp of the firstpass suture passer, the rack part of it was damaged (nonetheless, the user was able to assemble and use it).Additionally, the wire was not bringing, it was pulled out with a grasper.The procedure was successfully completed with a delay of less than 30 minutes using the same device.There was no damage to the patient's health.No further complications were reported.

Manufacturer Narrative

H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found the complaint device, the upper jaw is missing a piece.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.The root cause could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include excessive force, tissue thickness, damage or debris on the device tip between passes.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.Corrected data: h6: medical device problem code.

• Brand Name: FIRSTPASS SUTURE PASSER
• Type of Device: PASSER
• 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: 18682345
• MDR Text Key: 335109182
• Report Number: 3006524618-2024-00061
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00817470000160
• UDI-Public: 00817470000160
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22-4035
• Device Lot Number: 0123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male