MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CRW PRECISION ARC SYSTEM STEREOTAXY

Catalog Number CRWPRECISE

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921); Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2017. Lot/serial number was not provided; should the product be returned a dhr review will be completed. A two year look back from (b)(6) 2015 to (b)(6) 2017 "trunion rings are sticking or is completely stuck " for product id crw precise shows that 22 complaints were received including this case. Root cause cannot be determined due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation and it was reported that the issue was resolved by the customer. The reported complaint is considered unconfirmed.

Manufacturer Narrative

A review of our device history records for the reported serial number (b)(4), lot number 129 indicated the device was manufactured and released to specification. This product is inspected at 100% per inspection requirements prior to leaving integra facility. No service history is on file for this device.

Event Description

The crwprecise frame was opened in the operating room (theatre) for a deep brain stimulation (dbs) surgery and it came packed in an incorrect position and seemed jammed to begin with in the locked position. The trunnions where subsequently unable to be opened. The surgery was still in progress when the complaint information came through. The patient was prepped for dbs case when an issue with the arc was found. Patient age and gender unknown. The crw arc was not set up on the patient as it could not be unlocked. There was a delay to surgery while another device was found; delay of approximately 1 hour. Surgery continued with crwasl borrowed from a nearby facility. Additional information 11aug2017: the territory manager was able to speak to the hospital contact and confirmed that the trunnions were indeed locked at the central sterile supply department (cssd) level prior to steam autoclaving and they have since resolved the tightness and locking of the trunnion mechanism in cssd. The trunnions of the crw have been unlocked and the product will not be returned.

• Brand Name: CRW PRECISION ARC SYSTEM
• Type of Device: STEREOTAXY
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6810851
• MDR Text Key: 246429100
• Report Number: 3004608878-2017-00255
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K944463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CRWPRECISE
• Device Lot Number: 129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown