MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SEEKER LEFT, RH MAXILLARY SINUS; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 6001-132-000

Device Problem Bent (1059)

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

Event Date 12/07/2016

Event Type  malfunction  

Event Description

It was reported that the tip of the device was found to be bent while at the user facility.Although requested, no further information was provided by the user facility.

Manufacturer Narrative

The reported event that the tip of the device was found to be slightly bent was confirmed during the visual inspection.Any physical impact to the navigated instrument can cause product damage or operational failure due to battery movement.

Event Description

It was reported that the tip of the device was found to be bent while at the user facility.Although requested, no further information was provided by the user facility.

• Brand Name: SEEKER LEFT, RH MAXILLARY SINUS
• 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: 6200330
• MDR Text Key: 63197699
• Report Number: 0001811755-2016-02907
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002732
• 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: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6001-132-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2014
• 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