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 Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2022

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 the distal portion of a cannulated pedicle screw jammed onto the guidewire while the screw was being implanted intraoperatively.When the two pieces were trying to be unstuck, the tulip detached from the remainder of the screw.Both the guidewire and screw were removed from the patient.Another screw was installed to complete the procedure.There was a 30-minute delay with no impact to the patient.

Manufacturer Narrative

Corrections in d4: lot number, d9, and h3.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

Event Description

It was reported that the distal portion of a cannulated pedicle screw jammed onto the guidewire while the screw was being implanted intraoperatively.When the two pieces were trying to be unstuck, the tulip detached from the remainder of the screw.Both the guidewire and screw were removed from the patient.Another screw was installed to complete the procedure.There was a 30-minute delay with no impact to the patient.

Event Description

It was reported that the distal portion of a cannulated pedicle screw jammed onto the guidewire while the screw was being implanted intraoperatively.When the two pieces were trying to be unstuck, the tulip detached from the remainder of the screw.Both the guidewire and screw were removed from the patient.Another screw was installed to complete the procedure.There was a 30-minute delay with no impact to the patient.

Manufacturer Narrative

Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation the returned device was examined.Visual inspection revealed the guide wire is stuck inside the screw head and the tulip has disassembled from the screw shank.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to wear through use over time.This event could also be attributed deformation of either device leading to the binding.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimvie¿s control.Device usage this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

• 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16102606
• MDR Text Key: 306795018
• Report Number: 3012447612-2023-00012
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 0088902435707
• UDI-Public: (01)0088902435707(10)AAW
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• 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: AAW
• 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: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male