MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 6.5MM X 50MM; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number 3505-6550

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2020

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: 3012447612-2020-00586.

Event Description

It was reported that two pathfinder nxt screws fractured in-situ when tightening the nut.The two screws were removed and replaced.There were no patient impacts.This is report two of two.

Manufacturer Narrative

Additional information in h6: method, results, and conclusions.This follow-up report is being submitted to relay additional information.The complaint is unrefuted for two (2) of two (2) path finder nxt implant (part number 3505-6545) for the reported failure of broken screw.Medical records were not provided for review.Device evaluation: the products were not returned and no photos, intra-op/post-op images, or surgical notes were provided, so an evaluation is unable to be performed.The complaint is non-verifiable for the reported failure of broken screw.Complaint history search: a complaint history search was conducted.Dhr review and related actions per dhr review, the parts were likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use this devices are used for treatment.Potential cause this event could possibly be attributed to off-axis forces capable of overcoming the material properties applied during impaction.With the given information, the definitive cause cannot be determined.

Event Description

It was reported that two pathfinder nxt screws fractured in-situ when tightening the nut.The two screws were removed and replaced.There were no patient impacts.This is report two of two.

Event Description

It was reported that two pathfinder nxt screws fractured in-situ when tightening the nut.The two screws were removed and replaced.There were no patient impacts.This is report two of two.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information and initially corrected information.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that two pathfinder nxt screws fractured in-situ when tightening the nut.The two screws were removed and replaced.There were no patient impacts.This is report two of two.

Manufacturer Narrative

Additional information in h6: component, impact, investigation type, and findings.Device evaluation: visual inspection revealed the tulip has disassembled from both of the returned screws.Device use: this devices are used for treatment.Potential cause: this event could possibly be attributed to off-axis forces capable of overcoming the material properties applied during impaction.With the given information, the definitive cause cannot be determined.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: CANNULATED POLYAXIAL SCREW 6.5MM X 50MM
• 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: jessica buzbee ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3038034523
• MDR Report Key: 10701549
• MDR Text Key: 212521261
• Report Number: 3012447612-2020-00587
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024335707
• UDI-Public: (01)00889024335707(10)AAO
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3505-6550
• Device Lot Number: AAQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1