MAUDE Adverse Event Report: INTEGRA BURLINGTON, MA, INC. CRW PRECISION ARC SYSTEM; STEREOTAXY

Catalog Number CRWPRECISE

Device Problems Sticking (1597); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2015

Event Type  malfunction  

Event Description

This is the second of two reports (same product id, same serial number, similar problem, different incidents).This report is in regards to the (b)(6) 2015 incident.The trunion locking wheels seized up and the user was unable to unlock and rotate the loaner device.On (b)(6) 2015, the integra sales representative was able to free up the device and got approval from the operating room manager at the user facility to leave the device on site as a loaner.It was resterilized and put into service.The same occurrence happened again during a deep brain stimulation (dbs) surgery on (b)(6) 2015.There was no patient injury.Surgery delay was reported (exact time not provided).Additional information has been requested.

Manufacturer Narrative

Linked to mfg report number: 1222895-2015-00045 integra has completed their internal investigation on 03/03/2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: trunion set screw was pushed in and made contact with spacer.Additionally, residue was found inside trunion.Device history record reviewed for this product id lot # p1013 manufactured on 06aug2010 show no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr¿s, variances or rework.(b)(4).Conclusion: the set screws were forced to go beyond their settings.Residue is likely due to oil or cleaning agent used in cleaning and may have contributed to the sticking.Capa has been initiated to address this issue.

• Brand Name: CRW PRECISION ARC SYSTEM
• Type of Device: STEREOTAXY
• Manufacturer (Section D): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; 22 terry avenue; burlington MA 01803
• Manufacturer (Section G): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; burlington MA 01803
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5250853
• MDR Text Key: 32365345
• Report Number: 1222895-2015-00044
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRWPRECISE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1