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 Disassembly (1168)

Patient Problem No Code Available (3191)

Event Date 04/12/2017

Event Type  Injury  

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.Reference reports 3012447612-2017-00173 thru 3012447612-2017-00175.

Event Description

It was reported that there were damaged threads on two closure tops and one pedicle screw disassembled during surgery.The threads of one closure top sheared off within the tulip of the pedicle screw during attempted assembly, then the pedicle screw's tulip detached from the screw shaft.On another pedicle screw, the threads of the closure top sheared off during final tightening.The construct of three pedicle screws, three closure tops, and one rod were removed and replaced with competitive products.There was a delay of 35-40 minutes, but no patient injury as a result.No pieces fell into the wound.This is report two of three for this event.

Manufacturer Narrative

The returned screw was evaluated.There was damage found on the screw head threads consistent with cross-threading and damage on the screw shank consistent with disassembly.The 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.The 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.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 device usage.

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 reports 3012447612-2017-00173 thru 3012447612-2017-00175 and 3012447612-2017-00294.

Event Description

It was reported that there were damaged threads on two closure tops and two pedicle screws disassembled during surgery.The threads of one closure top sheared off within the tulip of the pedicle screw during attempted assembly, then the pedicle screw's tulip detached from the screw shaft.On another pedicle screw, the threads of the closure top sheared off during final tightening, then the pedicle screw's tulip detached from the screw shaft.The construct of three pedicle screws, three closure tops, and one rod were removed and replaced with competitive products.There was a delay of 35-40 minutes, but no patient injury as a result.No pieces fell into the wound.This is report two of four 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
• 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: 6614619
• MDR Text Key: 76751005
• Report Number: 3012447612-2017-00174
• 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: distributor,health profession
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3505-6545
• Device Lot Number: 86NR
• Other Device ID Number: (01)00889024335707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: 06/28/2017; 11/15/2017
• Supplement Dates FDA Received: 07/26/2017; 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2015
• 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
• Patient Outcome(s): Required Intervention