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

Catalog Number CRWPRECISE

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2015

Event Type  malfunction  

Event Description

The tri winged screw on the probe holder guide block was not tensioning and releases during lead placement.There was no pt contact, no pt injury or delay in surgery.Add'l info received on 03/04/2015: the (b)(6) male pt underwent dbs (deep brain stimulation) surgery on (b)(6) 2015.The operation proceeded and was completed using a replacement product.

Manufacturer Narrative

Integra has completed their internal investigation on 06/03/2015.The investigation included: methods: eval of actual device, review of device history records, review of complaint history; results: eval of device: the tri winged on probe holder guide block was not tensioning.Device history record was reviewed for this product id (crwpresice), lot# p1109, manufactured on 12/12/2012 shows no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr's, variances or rework.A two year review of complaints history this reported failure and or related to "guide block is not tensioning and releases during placement" for this product id shows that 2 complaints were received including this case.No new design or mfg trends have been identified.

• Brand Name: CRW PRECISION ARC SYSTEM
• Type of Device: STEREOTACY
• Manufacturer (Section D): INTEGRA BURLINGTON, MA, INC; burlington MA 01803
• Manufacturer Contact: rowena bunuan ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4834595
• MDR Text Key: 5910300
• Report Number: 1222895-2015-00026
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K944463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• 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: 03/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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
• Patient Age: 59 YR