MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INSTRUMENT BATTERY; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6000-006-000
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at receipt at the user facility a foreign particle was found in the sterile packaging of the instruments battery.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that at receipt at the user facility a foreign particle was found in the sterile packaging of the instruments battery.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: INSTRUMENT BATTERY
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7138500
• Report Number: 0001811755-2017-02484
• Device Sequence Number: 1069002
• Product Code: HAW
• UDI-Device Identifier: 04546540245045
• UDI-Public: (01)04546540245045
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K993239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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
• Operator of Device: Health Professional
• Device Model Number: 6000-006-000
• Device Catalogue Number: 6000006000
• Device Lot Number: 2017050968
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1