MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO THORACIC PEDICLE FEELER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 6002-350-000

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2016

Event Type  malfunction  

Event Description

It was reported that during a procedure conducted at the user facility the tip of the device was bent.No impact to the patient or procedural delays were reported with this event.

Manufacturer Narrative

The reported event that tip of the device was bent was confirmed through the visual inspection.It was observed that the tip was deformed.Any physical impact to the navigated instrument can cause product damage or operational failure due to battery movement.

Event Description

It was reported that during a procedure conducted at the user facility the tip of the device was bent.No impact to the patient or procedural delays were reported with this event.

• Brand Name: THORACIC PEDICLE FEELER
• 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: 5811724
• MDR Text Key: 50078871
• Report Number: 0001811755-2016-01220
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012380
• 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: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6002-350-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2016
• 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