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

Catalog Number 22-4038

Device Problem Mechanical Jam (2983)

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

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during a shoulder surgery the firstpass needle fired outside jaw instead of through suture capture and needle as well as jaw got stuck in the locked position, with the tendon in between.Then they had to use gold awl to open up jaw of the passer.The procedure was completed with a backup device with no delay or patient injury 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 devices and the reported incident.Visual inspection shows no manufacturing abnormalities on the device.The instrument was returned with an open bracket.During the "functional" evaluation an attempt was made to test the basic functions of this "instrument".The "first" step of the trigger performed as intended; the second step of the trigger performed as specified and the needle could be deployed/fired as intended; after releasing and squeezing the lever the jaw closed and the needle grasp the cobraid blue 38¿ test suture and "deploy" the needle through an om 3003 test tissue foam model.No functional issues were detected during the tests; the complaint was not verified and the root cause could not be defined with certainty.Factors that have nothing to do with the design and manufacture of the devices and that may have contributed to the complaint event are (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: 8497674
• MDR Text Key: 141569821
• Report Number: 3006524618-2019-00173
• 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: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• 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: 2024135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1