MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ORTHOMAP® VERSATILE HIP 2.0 SOFTWARE; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number 6007-616-000

Device Problem Imprecision (1307)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2017

Event Type  malfunction  

Event Description

It was alleged by the user facility to the sales representative that during a navigation procedure, the first length measured 10mm long.It was alleged that the user facility commented that was not possible, if anything it should be short.The user facility put in a new "head and neck" that should have made it read 7mm long (3mm shorter).The navigation unit read an actual value of 3mm short (13mm shorter) which is what the customer thought was accurate.It was reported that there were no known surgical delays or medical intervention needed.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document device evaluation results.

Event Description

It was alleged by the user facility to the sales representative that during a navigation procedure, the first length measured 10mm long.It was alleged that the user facility commented that was not possible, if anything it should be short.The user facility put in a new "head and neck" that should have made it read 7mm long (3mm shorter).The navigation unit read an actual value of 3mm short (13mm shorter) which is what the customer thought was accurate.It was reported that there were no known surgical delays or medical intervention needed.

• Brand Name: ORTHOMAP® VERSATILE HIP 2.0 SOFTWARE
• Type of Device: EAR, NOSE, AND THROAT 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: 7085206
• MDR Text Key: 93848940
• Report Number: 0001811755-2017-02403
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

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 Catalogue Number: 6007-616-000
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 05/03/2018
• Supplement Dates FDA Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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