MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. FINAL DRIVER SHORT; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number 3570-1

Device Problem Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference report 3012447612-2017-00202.

Event Description

It was reported that two drivers were found starting to wear.There was no surgical impact reported as a result of this issue.This is report two of two for this event.

Manufacturer Narrative

The returned driver was evaluated.The corners of the hex tip have worn from repeated uses.However, a functional check using mating devices found the driver to operate as expected.There were no manufacturing issues detected which would have contributed to this event.The labeling was reviewed and was found to contain sufficient instructions for usage.

Manufacturer Narrative

Further review of this event found that there was not a death or serious injury associated with this event.This event would not likely lead to a death or serious injury if it were to recur.

• Brand Name: FINAL DRIVER SHORT
• Type of Device: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW 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: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 6635606
• MDR Text Key: 77421441
• Report Number: 3012447612-2017-00203
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 3570-1
• Device Lot Number: 77KP
• Other Device ID Number: (01)00889024336483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: 10/09/2017; 05/24/2018
• Supplement Dates FDA Received: 10/17/2017; 06/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1