MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 4.5MM X 35MM; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number 3505-4535

Device Problem Disassembly (1168)

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

Event Date 01/15/2018

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.Reference reports 3012447612-2018-00190 thru 3012447612-2018-00197.

Event Description

It was reported that two screws disassembled during an attempt to reinstall them and six closure tops were cross-threaded during surgery.Alternative screws and closure tops were used to complete the procedure without reported patient impacts.This is report two of eight for this event.

Manufacturer Narrative

The device was not returned so an evaluation was unable to be performed, no results are available, and no conclusions can be drawn.A review of the dhr did not identify any manufacturing issues which would have contributed to this event.

• Brand Name: CANNULATED POLYAXIAL SCREW 4.5MM 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: 7265188
• MDR Text Key: 100019171
• Report Number: 3012447612-2018-00191
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3505-4535
• Device Lot Number: 81LS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1