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	06/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During the service evaluation process conducted at the manufacturer facility it was observed that the battery compartment broke off posing 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 during testing at the manufacturer 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: 8786730
• Report Number: 0001811755-2019-02278
• Device Sequence Number: 2338670
• Product Code: HAW
• UDI-Device Identifier: 04546540245090
• UDI-Public: 04546540245090
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/12/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1