MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED DORSAL HEIGHT & REVISION DRIVER; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number 3558-50

Device Problem Fracture (1260)

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

Event Date 11/19/2018

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that the tip of a driver broke off in a screw head while adjusting the height of the screw during surgery.The screw was removed and replaced with an alternative screw to complete the procedure, so the patient did not retain the device fragment.There were no reported patient impacts associated with this event.

Manufacturer Narrative

Udi number: na.Additional information: method, results, and conclusions - the returned driver was examined.A portion of the tip has fractured off of one side, indicating that an off-axis force was applied to the device during usage.There were no manufacturing issues detected which would have contributed to this event.

Event Description

It was reported that the tip of a driver broke off in a screw head while adjusting the height of the screw during surgery.The screw was removed and replaced with an alternative screw to complete the procedure, so the patient did not retain the device fragment.There were no reported patient impacts associated with this event.

• Brand Name: CANNULATED DORSAL HEIGHT & REVISION DRIVER
• 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: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 8182057
• MDR Text Key: 130972348
• Report Number: 3012447612-2018-01015
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

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: 3558-50
• Device Lot Number: 69HX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1