MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAKAGAWA SERRATED KNIFE TIP, UNIVERSAL; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5450800305
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other text : device not returned.
Event or Problem Description
It was reported that during the shaving of a spinal cord tumor, the dura of the patient was perforated.There was no delay or medical intervention reported, and the procedure was completed successfully with no other adverse consequences reported.
Additional Manufacturer Narrative
The event of a broken tip was retracted.
Event or Problem Description
It was reported that during the shaving of a spinal cord tumor, the dura of the patient was perforated.There was no delay or medical intervention reported, and the procedure was completed successfully with no other adverse consequences reported.
Event or Problem Description
It was reported that during the shaving of a spinal cord tumor, the tip broke and the dura of the patient was perforated.There was no delay or medical intervention reported, and the procedure was completed successfully with no other adverse consequences reported.

• Brand Name: NAKAGAWA SERRATED KNIFE TIP, UNIVERSAL
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8470420
• Report Number: 0001811755-2019-01055
• Device Sequence Number: 19313134
• Product Code: LFL
• UDI-Device Identifier: 37613252026663
• UDI-Public: 37613252026663
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5450800305
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 05/27/2019; 05/27/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/28/2019; 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1