MAUDE Adverse Event Report: ARTHROCARE CORPORATION 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 08/24/2018

Event Type  malfunction  

Event Description

It was reported that while manipulating the handle, when needle come out, the upper jaw broke.Broken piece was removed from patient and procedure was completed with a backup device.No patient injury or delay was reported.

Manufacturer Narrative

The returned device, intended for use in treatment, was returned for evaluation.There was a relationship found between the device and the reported incident.Visual inspection shows a device which was returned deployed with an open bracket.One half of the self-capturing is detached and was not returned with the device.There were no manufacturing abnormalities found on the device.During functional evaluation it was tried to activate the instrument.The needle can be deployed by pressing the levers; however the instrument is damaged and cannot be use as intended.The complaint was verified and the cause could not be defined with certainty.Factors that have nothing to do with the design and manufacture of the device and that may have contributed to the complaint event are described: excessive force should not be applied to the device and its levers when manipulating soft tissue, bones or hard objects.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 CORPORATION; 7000 west william cannon drive; austin TX 78735
• MDR Report Key: 7891535
• MDR Text Key: 120973500
• Report Number: 3006524618-2018-00488
• 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: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22-4038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1