MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 7 TO 13MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 6000-999-003

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

Patient Problem No Patient Involvement (2645)

Event Date 09/27/2019

Event Type  malfunction  

Event Description

It was reported that during set up it was observed that the washer was broken and missing from the device; this poses the 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 setup at the user facility, there was no patient involvement and no delay to a surgical procedure.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document device evaluation results.

Event Description

It was reported that during set up it was observed that the washer was broken and missing from the device; this poses the 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 setup 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 7 TO 13MM
• 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; DE D-79111
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 9221176
• MDR Text Key: 163227451
• Report Number: 0001811755-2019-03294
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04546540391919
• UDI-Public: 04546540391919
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6000-999-003
• Device Catalogue Number: 6000-999-003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2018
• 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