MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 6.5MM X 35MM; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number 3505-6535

Device Problem Disassembly (1168)

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

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.However, photos were provided and used for the evaluation.There was some visible damage to the tulip head connection mechanism which likely occurred during insertion and may have led to this failure.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain sufficient instructions regarding device installation.Reference report 3012447612-2017-00210.

Event Description

It was reported that a polyaxial screw fractured within surgery when the surgeon tried to remove one of the instruments used for installation.Investigation by zimmer biomet personnel determined that two polyaxial screws had disassembled.The procedure was completed using alternative screws.There were no reports of patient injury associated with this event.This is report two of two for this event.

• Brand Name: CANNULATED POLYAXIAL SCREW 6.5MM X 35MM
• 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: 6646782
• MDR Text Key: 77769220
• Report Number: 3012447612-2017-00211
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3505-6535
• Device Lot Number: 85ME
• Other Device ID Number: (01)00889024335684
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1