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

Catalog Number 72290129

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Perforation (2001)

Event Date 11/15/2023

Event Type  Injury  

Event Description

It was reported that during a shoulder surgery, the suture capture of the firstpass mini felt out.The fallen piece was found in the joint space of the shoulder.The broken piece was removed from the patient but an additional incision had to be made to gain access to retrieve the broken piece.The procedure was successfully completed with a delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Internal complaint reference: (b)(4).H10 h3, 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.The instructions for use were 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.A clinical review states that in the absence of the requested medical documentation, clinical factors which could have contributed to the reported event could not be definitively concluded, and a causal relationship between the s+n firstpass mini left and the reported adverse event could not be confirmed.Should any additional relevant medical information be provided, this case would be re-assessed.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.Internal complaint reference: (b)(4).

• Brand Name: FIRSTPASS MINI LEFT
• 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: 18290988
• MDR Text Key: 330045360
• Report Number: 3006524618-2023-00499
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556694565
• UDI-Public: 00885556694565
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

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 Catalogue Number: 72290129
• Device Lot Number: 2096102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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 Outcome(s): Required Intervention