MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO VECTOR CALIBRATION DEVICE (VCD); NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 6000-008-000

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2016

Event Type  malfunction  

Event Description

It was reported that the interface of the device was loose during inspection.No patient involvement or procedural delays were reported with the event.

Manufacturer Narrative

The reported event that the metal capture is loose was duplicated through the device inspection.It was observed that the screws at the vcd mechanics were loose.Any physical impact to the navigated instrument can cause the reported event.

Event Description

It was reported that the interface of the device was loose during inspection.No patient involvement or procedural delays were reported with the event.

• Brand Name: VECTOR CALIBRATION DEVICE (VCD)
• 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: 6200362
• MDR Text Key: 63198132
• Report Number: 0001811755-2016-02910
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993239
• 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: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 6000-008-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• 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