MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED 5.5 POLYAXIAL SCREW 6.5X45; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Model Number N/A

Device Problem Material Deformation (2976)

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

Event Date 10/02/2020

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: 3012447612-2020-00591 to 3012447612-2020-00594.

Event Description

Two pathfinder nxt closure tops and screws stripped during tightening within surgery.They were removed and replaced with new screws and closure tops to complete the procedure.There were no reported patient impacts.This is report four of four for this event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information: h3, h6 (methods, results, conclusions).The complaint is unconfirmed for one path finder nxt screw for the reported failure of stripped during implantation but confirmed for damaged tulip head.Visual inspection reveals the screw is deformed with the shaft being disconnected from the tulip.The screw is intact but the top of the tulip is visibly damaged (stripped thread at top of the tulip head).The device was likely conforming when it left zimmer biomet's control.Currently, no action is recommended.

Event Description

Two pathfinder nxt closure tops and screws stripped during tightening within surgery.They were removed and replaced with new screws and closure tops to complete the procedure.There were no reported patient impacts.This is report four of four for this event.

• Brand Name: CANNULATED 5.5 POLYAXIAL SCREW 6.5X45
• Type of Device: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10785914
• MDR Text Key: 214580504
• Report Number: 3012447612-2020-00594
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024335707
• UDI-Public: (01)00889024335707(10)85LS
• Combination Product (y/n): N
• PMA/PMN Number: K132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3505-6545
• Device Lot Number: 85LS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1