MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRYKER NAV3(R) PLATFORM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 7700-700-000

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 11/30/2017

Event Type  malfunction  

Event Description

It was reported that the navigation system is crashing at the user facility.A system crashing could necessitate professional medical or surgical intervention (to prevent permanent impairment.There is no known associated procedure.No significant delays or known impact to the patient were associated with the event.

Manufacturer Narrative

The device was not returned for evaluation; therefore, a root cause could not be determined for the event.Log files were not available for investigation.

Event Description

It was reported that the navigation system is crashing at the user facility.A system crashing could necessitate professional medical or surgical intervention (to prevent permanent impairment.There is no known associated procedure.No significant delays or known impact to the patient were associated with the event.

• Brand Name: STRYKER NAV3(R) PLATFORM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7145972
• MDR Text Key: 95841305
• Report Number: 0001811755-2017-02490
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

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: 7700-700-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 05/14/2018
• Supplement Dates FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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