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

Model Number 6002-350-000

Device Problems Image Display Error/Artifact (1304); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2019

Event Type  malfunction  

Event Description

The user facility reported that during inspection, the unit was reported to have a wobble, loose tip or handle; this poses the risk of inaccuracy and revision surgeries.No medical intervention and no adverse consequences were reported with this event.As this event occurred during inspection 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.H3 other text : discarded.

Event Description

The user facility reported that during inspection, the unit was reported to have a wobble, loose tip or handle; this poses the risk of inaccuracy and revision surgeries.No medical intervention and no adverse consequences were reported with this event.As this event occurred during inspection at the user facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: THORACIC PEDICLE FEELER
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9186541
• MDR Text Key: 162356113
• Report Number: 0001811755-2019-03233
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04546540503824
• UDI-Public: 04546540503824
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6002-350-000
• Device Catalogue Number: 6002-350-000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 05/13/2020
• Supplement Dates FDA Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1