MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. NAVIGATION CANNULATED T27 BONE SCREW DRIVER VITAL NAVIGATION SYSTEM

Catalog Number 854M0021

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: visual inspection revealed that the tip of the driver is twisted. Potential cause root cause was unable to be determined. This event could possibly be attributed to wear through use over time or multiple sterilization cycles. It could also be attributed to off-axis forces applied during use. Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control. Device use this device is used for treatment. If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

Event Description

The tip of a screw inserter was found to be twisted during a routine inspection. The specific surgical or patient information is unknown.

• Brand Name: NAVIGATION CANNULATED T27 BONE SCREW DRIVER
• Type of Device: VITAL NAVIGATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 13690653
• MDR Text Key: 286768375
• Report Number: 3012447612-2022-00057
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00887868310232
• UDI-Public: (01)00887868310232(10)312476
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 854M0021
• Device Lot Number: 312476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse