MAUDE Adverse Event Report: ARTHROCARE CORP. FIRSTPASS SUTURE PASSER

Catalog Number 22-4035

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during the procedure, the top jaw of the firstpass has come away from the rest of the handle.A backup device was available to complete the procedure with no delay or patient injuries.Attempts were made to retrieve further information but no response has been received from the complainant.

Manufacturer Narrative

The returned instrument, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection under magnification shows a first pass suture passer which was returned with a detached top bracket.The suture capture inside the top bracket is available; during the functional evaluation the ratchet release and the lever were tested without issue.Further functional test cannot be verified due to the missing component.The complaint was verified and the root cause could not be determined with certainty.However likely a root cause could be (1) mechanical component failure (2) excessive force used (3) tissue thickness.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: FIRSTPASS SUTURE PASSER
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8775325
• MDR Text Key: 150542772
• Report Number: 3006524618-2019-00325
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00817470000160
• UDI-Public: 00817470000160
• 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: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22-4035
• Device Lot Number: 20618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1