MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 6.5MM X 50MM; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number 3505-6550

Device Problems Disassembly (1168); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 03/21/2018

Event Type  Injury  

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 3012447612-2018-00352.

Event Description

It was reported that the tulip of a pedicle screw disassembled from its shaft and became stuck in a reduction sleeve during surgery.There was a delay greater than 30 minutes associated with removing the screw shank and replacing the screw with an alternative pedicle screw.However, no patient harm was reported.This is report one of two for this event.

Manufacturer Narrative

The tulip portion of the pedicle screw was returned and was found to be wedged within the mating sleeve.The threaded shaft had disassembled from the tulip and was not returned.The threads within the tulip were found damaged in a manner consistent with cross-threading the closure top within the tulip during tightening.The tulip was wedged within the sleeve because of thread fragments apparently from the closure top which was stuck between the sleeve and tulip.It was likely that the sleeve and pedicle screw were not appropriately aligned, which led to the cross-threading, damaged threads, fractured threads, and disassembly.A review of the dhr did not identify any issues which would have contributed to this event.

• Brand Name: CANNULATED POLYAXIAL SCREW 6.5MM X 50MM
• 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: 7432252
• MDR Text Key: 105520009
• Report Number: 3012447612-2018-00351
• 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
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3505-6550
• Device Lot Number: 85LX
• Other Device ID Number: (01)00889024335714(10)85LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2015
• 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
• Patient Age: 87 YR
• Patient Weight: 132