MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ORTHOMAP® PRECISION KNEE 5.0 SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 6003-655-000

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2016

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure conducted at the user facility the system was inaccurate.Pre-op the anatomy was identified to be approximately 6-7 degrees varus, and intra-op the system showed the anatomy to approximately 8-9 degrees valgus.The procedure was completed successfully with the use of a stemmed implant, requiring a more lengthy and invasive approach.No adverse consequences were associated with the event; a delay of unknown length was reported.

Manufacturer Narrative

Device not returned.

Event Description

It was reported that during a surgical procedure conducted at the user facility the system was inaccurate.Pre-op the anatomy was identified to be approximately 6-7 degrees varus, and intra-op the system showed the anatomy to approximately 8-9 degrees valgus.The procedure was completed successfully with the use of a stemmed implant, requiring a more lengthy and invasive approach.No adverse consequences were associated with the event; a delay of unknown length was reported.

• Brand Name: ORTHOMAP® PRECISION KNEE 5.0 SOFTWARE
• 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: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6165932
• MDR Text Key: 62145151
• Report Number: 0001811755-2016-02833
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022579
• 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: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6003-655-000
• Device Lot Number: VERSION 4.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2017
• 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