MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FEMURAL TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 6003-010-000

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2017

Event Type  malfunction  

Event Description

During a surgical procedure conducted at the user facility a piece o the device disassembled.No patient involvement or procedural delays were associated with the event by the initial reporter.

Manufacturer Narrative

The complaint was confirmed based on the device evaluation.Any physical impact to the navigated instrument can cause product damage.

Event Description

During a surgical procedure conducted at the user facility a piece of the device disassembled.No patient involvement or procedural delays were associated with the event by the initial reporter.

• Brand Name: FEMURAL TRACKER
• Type of Device: ORTHOPEDIC 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: 6614842
• MDR Text Key: 76767473
• Report Number: 0001811755-2017-01292
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04546540246011
• UDI-Public: (01)04546540246011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

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: Health Professional
• Device Model Number: 6003-010-000
• Device Catalogue Number: 6003-010-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: 06/26/2017
• Supplement Dates FDA Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2016
• 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