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

Catalog Number 6002-350-000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

It was reported that the shaft of the thoracic pedicle feeler was loose from the electronic housing during testing prior to the procedure, which has the potential to cause accuracy issues if not noticed by the user during a procedure.There was no patient involvement and no adverse consequences associated with the device.

Event Description

It was reported that the shaft of the thoracic pedicle feeler was loose from the electronic housing during testing prior to the procedure, which has the potential to cause accuracy issues if not noticed by the user during a procedure.There was no patient involvement and no adverse consequences associated with the device.

Manufacturer Narrative

The reported event that the tip is loose from the navigation handpiece was confirmed.During the device inspection, the threaded pin was found to not be screwed down and the loctite was missing.This is the reason for the loose tip.The device was repaired and put back into stryker stock.

• 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 MI 49001 D-7
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3672748
• MDR Text Key: 4320591
• Report Number: 0001811755-2014-00849
• 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: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• 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: 03/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: No
• 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