MAUDE Adverse Event Report: ZIMMER BIOMET SPINE CNNLTD 5.5 PLYSCRW 6.5X45; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number 3505-6545

Device Problem Disassembly (1168)

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

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 tulip of the pedicle screw detached from the screw shank while reducing the rod in surgery.The screw shaft was not removed from the patient.There were no reports of immediate injury to the patient.

Manufacturer Narrative

Initially, it was reported that the screw shank was not removed from the patient.However, the complaint device received included both the screw tulip head and shank.The returned screw was evaluated.The tulip was found disassembled from the screw shaft.Slight deformation was visible on the swivel ring; this deformation allowed the other components to disassemble.The cause is likely attributed to high forces applied to the screw during use.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 instructions regarding proper device usage.

• Brand Name: CNNLTD 5.5 PLYSCRW 6.5X45
• Type of Device: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: geoffrey gannon ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 6201213
• MDR Text Key: 63186830
• Report Number: 3004485144-2016-00428
• 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,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3505-6545
• Device Lot Number: 85LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2015
• 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