MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO POINTER, STRAIGHT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6007-011-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a surgical procedure at the user facility the tip was broken.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
It was determined after receiving further clarification from the customer that the device was found deformed at set up, and not during a procedure.As the device is registered before each procedure for its shape, a deformation before a procedure and device validation is not a reportable event per cfr 21, part 803 as there is no risk of inaccuracy.This supplemental is being filed to identify a mdr was not required for this event.
Event or Problem Description
It was reported that prior to a surgical procedure at the user facility the tip was broken.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: POINTER, STRAIGHT
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8175998
• Report Number: 0001811755-2018-02826
• Device Sequence Number: 19339067
• Product Code: HAW
• UDI-Device Identifier: 04546540392114
• UDI-Public: 04546540392114
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K993239
• 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): 01/11/2019

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: 6007-011-000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1