MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SUCTION TUBE, 2.7MM RIGHT POSTERIOR FOSSA; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6001-088-227
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was found to have had a broken piece next to the leds.No medical intervention and no adverse consequences were reported with this event.There was no reported patient involvement or delays to a surgical procedure.
Additional Manufacturer Narrative
It was determined after receiving further clarification from receipt of the device that this event was not a reportable event per cfr 21, part 803.This supplemental is being filed to identify a mdr was not required for this event.The piece of the device that was originally described as being separate from the device's led assembly was verified to be part of the led assembly.The assembly is a large, visually apparent piece of the device that would not share the same potential risk and harm as an independent or unknown component as originally described.
Event or Problem Description
It was reported that the device was found to have had a broken piece next to the leds.No medical intervention and no adverse consequences were reported with this event.There was no reported patient involvement or delays to a surgical procedure.

• Brand Name: SUCTION TUBE, 2.7MM RIGHT POSTERIOR FOSSA
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7768035
• Report Number: 0001811755-2018-01574
• Device Sequence Number: 11259178
• Product Code: HAW
• UDI-Device Identifier: 04546540245854
• UDI-Public: 04546540245854
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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): 11/02/2018

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: 6001-088-227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1