MAUDE Adverse Event Report: ARTHROCARE CORP. SMARTSTITCH PP CONNECTOR; ACCESSORIES,ARTHROSCOPIC

Catalog Number OM-8010

Device Problem Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/31/2017

Event Type  malfunction  

Event Description

It was reported that the jaw on the perfect passer fell off in the patient.

Manufacturer Narrative

A relationship between the device and reported incident was established.From the information provided, jaw on the perfectpasser fell off in the patient.No additional information was obtained.Visual inspection shows the returned connector was received with its s-clamp removed and not returned.An internal investigation is currently in process to determine the exact root cause for the jaws falling off; however, a preliminary investigation was performed and the investigation revealed that the angular dimension of the s-clamp hook was out of specification.Changes to the component have been implemented to prevent this failure.The instruction for use (ifu) were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality including inspection of the instrument prior to use.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SMARTSTITCH PP CONNECTOR
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon; austin, TX 78735
• MDR Report Key: 7023204
• MDR Text Key: 92777157
• Report Number: 3006524618-2017-00354
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OM-8010
• Device Lot Number: 1194208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 74 YR