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

Catalog Number 22-4038

Device Problem Mechanical Jam (2983)

Patient Problem Rupture (2208)

Event Date 09/22/2022

Event Type  Injury  

Event Description

It was reported that during a rotator cuff repair procedure, the suture was being passed through the shoulder with a firstpass device, but the jaw locked closed inside the patient.In consequence, the surgeon ended up removing the device by tearing through the patient rotator cuff tissue.The procedure was successfully completed using a competitor device.There was a non-significant surgical delay of 10-15min, and no further complications were reported.

Manufacturer Narrative

(b)(4).

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 with any original packaging.The lever and trigger are fully compressed against the handle.The suture passer needle is fully extended and pulled outside of the jaw.The jaw is locked down over the needle.The suture capture has no defect.Bio debris is present.A functional evaluation revealed the lever and trigger will not release.Nor will the jaw open with manual pressure.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.The root cause has been associated with a mechanical component failure.Factors that could have contributed to the failure include rough handling or excessive force to the device.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 CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15577597
• MDR Text Key: 301490023
• Report Number: 3006524618-2022-00440
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00885556724545
• UDI-Public: 885556724545
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2024
• Device Catalogue Number: 22-4038
• Device Lot Number: 2070220
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2022
• Date Device Manufactured: 03/17/2021
• 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): Other; Required Intervention