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

Catalog Number 22-4038

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2019

Event Type  malfunction  

Event Description

It was reported that during a rotator cuff repair with firstpass to catch the ultratape, the jaws did not open.When the surgeon pulled out the device from the rotator cuff and checked, it was broken the lock.The procedure was successfully completed with the same part number of the back-up device.No patient injury was reported.No significant delay was reported.

Manufacturer Narrative

The returned device, intended for use in treatment, was returned as an mdr for evaluation.There was no relationship found between the device and the reported incident.Visual inspection shows no manufacturing abnormalities on the device.The instrument was returned with an open bracket.There were no manufacturing abnormalities found on the device.During the functional evaluation, the first step of the trigger with the locking mechanism was tested and performed as intended; the second step of the trigger was also tested and performed as specified.The needle could be deployed/fired as intended; during further functional tests the lever was squeezed, the jaw closed and the needle grasp a cobraid blue 38¿ test suture and deployed the needle through an om-3003 test tissue.No functional issues were detected during the tests, not as reported; the complaint was not verified and the root cause could not be defined with certainty.Factors unrelated to the design and manufacture of the device which could have contributed to the complaint event are outlined in the precautionary states in the instruction for use provided with the device associated with set-up and use of the device; a possible factor for the complaint could be if (1) excessive force is be applied to the device when manipulating soft tissue, bone, or hard objects (2)instrument used as a lever for manipulating hard tissue or bone; there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 9079582
• MDR Text Key: 159003825
• Report Number: 3006524618-2019-00454
• 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: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2021
• Device Catalogue Number: 22-4038
• Device Lot Number: 2024137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1