MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAVIGATION KIT FOR NAVSUITE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 7700-009-010

Device Problems Imprecision (1307); Malposition of Device (2616)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 10/21/2015

Event Type  Injury  

Manufacturer Narrative

Please refer to mfr.Report number 0002249697-2015-04079 for a report filed on the concomitant device, triathlon p/a cr beaded #4l (catalog number: 5517f401, serial number: (b)(4)).

Event Description

It was reported that during a bilateral triathlon knee procedure conducted at the user facility, the navigation screen blinked white as the left femur cut was made.On a postoperative x-ray, it was confirmed that the left femur was cut in 6 degrees valgus.A revision surgery of the left knee was completed successfully, approximately one week later.

Manufacturer Narrative

The reported event that the femur was cut in 6° valgus could not be confirmed based on the provided postoperative x-rays.Instead, the x-rays show a leg alignment of about 6° valgus.However, upon review of the log files and patient files, there were no clear indications that the registration may have been performed poorly or that the navigation system did not function properly.

Event Description

It was reported that during a bilateral triathlon knee procedure conducted at the user facility, the navigation screen blinked white as the left femur cut was made.On a postoperative x-ray, it was confirmed that the left femur was cut in 6 degrees valgus.A revision surgery of the left knee was completed successfully, approximately one week later.

• Brand Name: NAVIGATION KIT FOR NAVSUITE
• 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: 5361938
• MDR Text Key: 35725500
• Report Number: 0001811755-2016-00052
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K993239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7700-009-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 01/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2009
• 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
• Patient Outcome(s): Other
• Patient Age: 72 YR