MAUDE Adverse Event Report: ARTHROCARE CORPORATION DISP FIRSTPASS STR PASSR SELF; PASSER

Catalog Number 22-4038

Device Problem Break (1069)

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

Event Date 01/13/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a shoulder arthroscopy, before using the firstpass device into the patient, it was noticed that the needle was broken.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: 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.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.

Manufacturer Narrative

Corrected data: h6: health effect - impact code.

Manufacturer Narrative

H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in original packaging.Bio debris is present in the suture capture and jaw.No other visible defect.A functional evaluation showed pulling the lever will close and lock the jaw.Pulling the lever and trigger simultaneously will deploy the suture passer needle as intended.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 the reported malfunction could not be duplicated during the investigation.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: DISP FIRSTPASS STR PASSR SELF
• 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: 18720910
• MDR Text Key: 335594140
• Report Number: 3006524618-2024-00072
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00885556724545
• UDI-Public: 885556724545
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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,Followup
• Report Date: 05/02/2024

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: 22-4038
• Device Lot Number: 2114449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 02/27/2024; 03/05/2024; 04/30/2024
• Supplement Dates FDA Received: 02/28/2024; 03/05/2024; 05/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• 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