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 Disassembly (1168); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference report 3012447612-2017-00229.

Event Description

Initially, a closure top and pedicle screw were returned without event details.Preliminary visual evaluation by zimmer biomet personnel found the closure top to have stripped threads and the pedicle screw's tulip head to be separated from the screw shank.Follow up was performed with the sender, who reported that the closure top was unable to be final tightened and kept rotating in the tulip of the pedicle screw during surgery.The threads on the closure top and pedicle screw both stripped.They were removed and replaced with alternative devices.Information regarding patient impact has been requested but not provided.This is report one of two for this event.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

Initially, a closure top and pedicle screw were returned without event details.Preliminary visual evaluation by zimmer biomet personnel found the closure top to have stripped threads and the pedicle screw's tulip head to be separated from the screw shank.Follow up was performed with the sender, who reported that the closure top was unable to be final tightened and kept rotating in the tulip of the pedicle screw during surgery.The threads on the closure top and pedicle screw both stripped.They were removed and replaced with alternative devices.There were no reports of patient injury associated with this event.This is report one of two for this event.

Manufacturer Narrative

Additional information: the returned screw was evaluated.There was damage found on the screw shaft splines which is consistent with tightening the rod and closure top within the tulip against the splines.There is also some damage on the top tulip thread consistent with cross-threading a closure top within the tulip.The root cause of the disassembly is likely attributed to the deformation of the splines associated with final tightening and subsequent loosening of the rod and closure top within the tulip.The root cause of the cross-threading is likely attributed to an incorrect assembly between the sleeve and the pedicle screw which allowed the closure top to move off-axis and cross-thread at the junction between the sleeve and the tulip.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain sufficient instructions regarding proper device usage and installation.

• 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: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 6660161
• MDR Text Key: 78188089
• Report Number: 3012447612-2017-00228
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• 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: 88MX
• Other Device ID Number: (01)00889024335707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1