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

Catalog Number CRWPRECISE

Device Problems Sticking (1597); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The right trunnion wheel locked up during set-up; before being placed on the patient.The scrub nurse could not unlock trunnion.After surgeon scrubbed in, the surgeon also tried force to loosen.Surgery delay reported (while surgeon sprayed in anti-fog fluid to loosen the trunnion wheel; no information about how long this delay was).The surgeon was then able to put the coordinates into frame and continue with the case as normal.Thee was no patient adverse event.No patient details were available.The territory manager has been in contact with the dbs product manager at medtronic to reiterate that medtronic appears to not be using the dedicated crw sterilization case for the crw, outside of integra's recommendations, and thus possibly contributing to these occurrences.

Manufacturer Narrative

Integra has completed their internal investigation on 28jun2016.The device was not returned for evaluation.Medtronic deemed the frame ¿able to be used as normal so no further interventions were taken¿.Device history record reviewed for this product id lot #148374 manufactured on october 29, 2013 show 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 look back in the complaint system for this reported failure and or related to " trunnion locking wheels seized (locked up)" for this product id shows that (b)(4) complaints were received including this case.In summary, product was not returned for investigation so no failure analysis was conducted.Capa has been issued to further investigate this reported failure.

• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5722669
• MDR Text Key: 48407318
• Report Number: 3004608878-2016-00157
• 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,health
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 05/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2013
• 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