MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 6.5MM X 45MM; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number 3505-6545

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2020

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: 3012447612-2020-00583, 3012447612-2020-00584 and 3012447612-2020-00585.

Event Description

It was reported three pathfinder nxt screws fractured during surgery.One of the screws broke in the surgeon¿s hands while assembling.The other two screws broke in-situ during the tightening of the nut.The fractured screws were removed and replaced with new ones.There were no reported patient impacts.This is report two of three for this event.

Event Description

It was reported three pathfinder nxt screws fractured during surgery.One of the screws broke in the surgeon's hands while assembling.The other two screws broke in-situ during the tightening of the nut.The fractured screws were removed and replaced with new ones.There were no reported patient impacts.This is report two of three for this event.

Manufacturer Narrative

Information was entered erroneously into h3; there are no changes from the initial report.Additional information in h6: method, results, and conclusions.This follow-up report is being submitted to relay additional information and initially corrected information.Device evaluation:the product number and lot numbers in the photograph match the complaint.Visual inspection reveals that the tulip head was detached from the screw.The complaint is confirmed for all three products based on the available pictures.Complaint history search: the complaint history search for disassembly of tulip head was performed.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.Potential cause with the given information, the definitive cause cannot be determined.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Manufacturer Narrative

Correction to: d1.Additional information: d6, d7,g3, h4.

Event Description

It was reported three pathfinder nxt screws fractured during surgery.One of the screws broke in the surgeon¿s hands while assembling.The other two screws broke in-situ during the tightening of the nut.The fractured screws were removed and replaced with new ones.There were no reported patient impacts.This is report two of three for this event.

Event Description

It was reported three pathfinder nxt screws fractured during surgery.One of the screws broke in the surgeon's hands while assembling.The other two screws broke in-situ during the tightening of the nut.The fractured screws were removed and replaced with new ones.There were no reported patient impacts.This is report two of three for this event.

Manufacturer Narrative

Additional information in h6: component, impact, and investigation type.Device evaluation: visual inspection reveals that the tulip head was detached from the screw.Device use: this devices are used for treatment.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 45MM
• 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: 10626625
• MDR Text Key: 209779839
• Report Number: 3012447612-2020-00584
• 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

• 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: AAO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 10/05/2020; 12/11/2020; 04/27/2022
• Supplement Dates FDA Received: 10/15/2020; 12/17/2020; 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1