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

Catalog Number 72290130

Device Problem Break (1069)

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

Event Date 11/30/2023

Event Type  malfunction  

Event Description

It was reported that during a shoulder procedure, the first pass mini jaw broke off in the patients shoulder.All broken parts were removed using a grasper.The procedure was successfully completed using a back-up device.There was a surgical delay less than 30 minutes and no further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

H10: internal complaint reference case-(b)(4).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.The upper jaw window has been fractured into two pieces.There are no other visible defects.A functional evaluation showed pulling the lever will close the remaining jaw portion 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.The root cause has been 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.

Manufacturer Narrative

H10 h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: FIRSTPASS MINI RIGHT
• 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: 18383933
• MDR Text Key: 331500031
• Report Number: 3006524618-2023-00515
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72290130
• Device Lot Number: 2119343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2023
• 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