MAUDE Adverse Event Report: ZIMMER BIOMET SPINE CNNLTD 5.5 PLYSCRW 7.5X55; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Model Number N/A

Device Problems Disassembly (1168); Device-Device Incompatibility (2919)

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

Event Date 09/21/2016

Event Type  Injury  

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 during a pathfinder nxt case, the surgeon attempted to insert a 7.5 x 55mm screw through a k-wire into the pedicle.However, half way into the vertebral body, the k-wire became stuck in the cannulation of the poly screw and there was difficulty in removing the k-wire.So the surgeon decided to back out the entire screw (along with the k-wire stuck in the middle cannulation).As he backed the screw out of the vertebral body and pedicle, he found out that the pedicle screw head and shank has become dislocated.To finish the surgery, he inserted a new k-wire and a new 7.5 x 55 mm screw.This was done successfully.

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.

Manufacturer Narrative

Additional information was received from the reporter, who stated the k-wire used in this event came from another set.The returned screw was evaluated.The tulip was found disassembled form the shaft and a k-wire was found stuck within the screw shaft.The k-wire was found to be a product which is not distributed as part of or intended to be used with the pathfinder nxt system.As such, the dimensions of the k-wire used do not meet those of the pathfinder nxt system and caused it to be lodged within the pedicle screw.The disassembly is likely related to the screw being partially installed, removed, and manipulated to remove the k-wire.A review of the manufacturing records did not indicate any issues which may have contributed to this event.The labeling was reviewed and found to contain indications for device usage and warnings against reuse of implants.

• Brand Name: CNNLTD 5.5 PLYSCRW 7.5X55
• 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: teresa george ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 6024798
• MDR Text Key: 57246579
• Report Number: 3004485144-2016-00279
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: PK132884
• 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,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3505-7555
• Device Lot Number: 79XP
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/18/2016; 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention