MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 11G 5IN MATCH-GROUND FOUR FACET TIP INTRODUCTION NEEDLE; INSTRUMENT, BIOPSY

Catalog Number	0306110000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Discarded.
Event or Problem Description
It was reported that the cannula broke off in the patient.No attempts were made to remove the device.The procedure was completed successfully and there were no additional adverse consequences reported.

• Brand Name: 11G 5IN MATCH-GROUND FOUR FACET TIP INTRODUCTION NEEDLE
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7657980
• Report Number: 0001811755-2018-01130
• Device Sequence Number: 13614456
• Product Code: KNW
• UDI-Device Identifier: 34546540434280
• UDI-Public: 34546540434280
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: 0306110000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1