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

Model Number 22-4038

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

Foreign zip code: (b)(6).

Event Description

It was reported that during the procedure, after grasping the rotator cuff tissue for the third time, the suture could not be captured, the first pass got broken inside the patient.Pieces were removed from patient.The procedure was completed with back-up device.No significant delay or patient injury were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h3,h6: the returned device used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records for the reported lot number 2024289 showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review for lot number 2024289 for the past 3 years found no related failures.Visual inspection shows a device which was returned deployed.The instrument was returned with an opened bracket.There were no manufacturing abnormalities found on the device.The jaw was broken and received separately.Functional evaluation revealed that the two step trigger performed as intended.The bracket could be opened /closed as specified.The needle could be extended without any issues.The complaint was verified and the root cause could be determined as an mechanical component failure.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.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
• MDR Report Key: 9311776
• MDR Text Key: 166066155
• Report Number: 3006524618-2019-00553
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: 22-4038
• Device Catalogue Number: 22-4038
• Device Lot Number: 2024289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1