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

Catalog Number 22-4038

Device Problem Break (1069)

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

Event Date 11/20/2018

Event Type  malfunction  

Event Description

It was reported that the top jaw broke off.Broken jaw was removed from the patient.Unknown if backup was available and how the issue was resolved.No patient injuries reported.

Event Description

It was reported that during rotator cuff repair, the top jaw broke off.And it was removed from the patient.Unknown if backup was available and how the issue was resolved.There was no significant delay and no patient injury or other complications were reported.

Manufacturer Narrative

The returned device, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship found between the device and the reported incident.Visual inspection shows a device which was returned deployed.The instrument was returned with an open bracket.The self-capturing inside the top bracket is missing.There were no manufacturing abnormalities found on the device.During functional evaluation the two step trigger performed as intended and the bracket could be closed and opened as specified.The needle could be fired.Further functional test could not be performed cause of the damage.The complaint was verified and the root cause could not be determined.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: 8134370
• MDR Text Key: 129578293
• Report Number: 3006524618-2018-00627
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2021
• Device Catalogue Number: 22-4038
• Device Lot Number: 2017414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1