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 Detachment of Device or Device Component (2907)

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

Event Date 07/19/2021

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 report 3012447612-2021-00303.

Event Description

It was reported that two screws disassembled intra-op after being removed to change their trajectories.The rod and closure tops had already been installed when the surgeon decided to change the screws' trajectories.New screws were used to complete the procedure without reported patient impacts.This is report one of two for this event.

Manufacturer Narrative

Corrected information in d4: udi number, d9, and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Inspection visual inspection revealed the tulips of both returned screws have disassembled from the screw shanks.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 zimmer biomet¿s control.Potential root cause with the given information, the definitive cause cannot be determined.Device use this device is used for treatment.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 two screws disassembled intra-op after being removed to change their trajectories.The rod and closure tops had already been installed when the surgeon decided to change the screws' trajectories.New screws were used to complete the procedure without reported patient impacts.This is report one of two for this event.

Manufacturer Narrative

Corrected d4: lot number.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 two screws disassembled intra-op after being removed to change their trajectories.The rod and closure tops had already been installed when the surgeon decided to change the screws' trajectories.New screws were used to complete the procedure without reported patient impacts.This is report one of two for this event.

• 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
• MDR Report Key: 12324717
• MDR Text Key: 266661654
• Report Number: 3012447612-2021-00302
• Device Sequence Number: 1
• Product Code: NKB
• 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,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• 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: AAT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1