MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INSTRUMENT TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 6007-008-000

Device Problem Disassembly (1168)

Patient Problem No Patient Involvement (2645)

Event Date 11/08/2016

Event Type  malfunction  

Event Description

It was reported that during testing conducted at the user facility, a button was found to be missing from the device.It was reported that no patient involvement or procedural delays are associated with this event.

Manufacturer Narrative

The reported event that there was no button on the device was confirmed through the device inspection.It was observed that the screw at the select button was broken off and the select button was missing.Any physical impact to the navigated instrument can cause product damage or operational failure due to battery movement.

Event Description

It was reported that testing conducted at the user facility a button was found to be missing from the device.It was reported that no patient involvement or procedural delays are associated with this event.

• Brand Name: INSTRUMENT TRACKER
• 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6150709
• MDR Text Key: 61606761
• Report Number: 0001811755-2016-02818
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6007-008-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2014
• 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