MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO POINT CALIBRATION DEVICE (PCD); NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6000-010-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that prior to a case, it was observed that the compartment that holds the battery is broken or cracked; this poses the risk of a small component being lost in the surgical site.No medical intervention and no adverse consequences were reported with this event.As this event occurred prior to a procedure at the user facility, there was no patient involvement and no delay to a surgical procedure.
Additional Manufacturer Narrative
Correction:.
Event or Problem Description
The customer reported that prior to a case, it was observed that the compartment that holds the battery is broken or cracked; this poses the risk of a small component being lost in the surgical site.No medical intervention and no adverse consequences were reported with this event.As this event occurred prior to a procedure at the user facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: POINT CALIBRATION DEVICE (PCD)
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8623561
• Report Number: 0001811755-2019-01749
• Device Sequence Number: 14018268
• Product Code: HAW
• UDI-Device Identifier: 04546540245090
• UDI-Public: 04546540245090
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: No Information
• Device Catalogue Number: 6000-010-000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1