MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 13 TO 20MM NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 6000-999-004

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 02/11/2020

Event Type  malfunction  

Event Description

It was reported that during preventative maintenance the device's screw was found missing. The screw missing poses a risk of a small component being lost in the surgical site. No medical intervention and no adverse consequences were reported with this event. As this event occurred during preventative maintenance at the user facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 13 TO 20MM
• 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; D-79111
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 9774906
• MDR Text Key: 181580369
• Report Number: 0001811755-2020-00599
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 6000-999-004
• Device Catalogue Number: 6000-999-004
• Device Lot Number: A/02/2018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse