MAUDE Adverse Event Report: AVALIGN GERMAN SPECIALTY INSTRUMENTS MILLENNIUM SURIGCAL CORP; K-WIRE

Model Number	Z16113001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned for evaluation by manufacturing.
Event or Problem Description
K-wire was inserted into vertebral bone.Screw was placed overk-wire, k-wire was screwed into the space and the tip of the k-wire broke off.K-wire broke off in the spinal cord area.Dr.Retrieved.This k-wire is not available for evaluation.

• Brand Name: MILLENNIUM SURIGCAL CORP
• Common Device Name: K-WIRE
• Manufacturer (Section D): AVALIGN GERMAN SPECIALTY INSTRUMENTS; 626 cooper ct; schaumburg IL 60173
• MDR Report Key: 9630177
• Report Number: 1421101-2020-00001
• Device Sequence Number: 2787681
• Product Code: JDW
• UDI-Device Identifier: 00190776135072
• UDI-Public: 00190776135072
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K100736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: Z16113001
• Device Catalogue Number: Z16113001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other