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

Catalog Number	6000-012-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during equipment testing conducted at the user facility it was observed that the tip of device was broken off.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the user facility, there was no patient involvement and no delay to a surgical procedure.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.The device evaluation shows the device broke as designed at the designated breaking point.It has been determined that if the device breaks at the designated breaking point, it does not pose a risk of causing or contributing to a serious injury or adverse event.This record is a follow up to denote the original filing was in error.
Event or Problem Description
It was reported that during equipment testing conducted at the user facility it was observed that the tip of device was broken off.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the user facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: SMALL POINTER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7812658
• Report Number: 0001811755-2018-01611
• Device Sequence Number: 1862215
• Product Code: HAW
• UDI-Device Identifier: 04546540245113
• UDI-Public: 04546540245113
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/18/2018

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 Catalogue Number: 6000-012-000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1