MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 4.5MM X 30MM; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number 3505-4530

Device Problem Disassembly (1168)

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2017

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 reports 3012447612-2017-00434 thru 3012447612-2017-00436.

Event Description

It was reported that the tulips of three pedicle screws detached from the threaded shafts outside of a surgical setting.There were no surgical or patient impacts.This is report two of three for this event.

Manufacturer Narrative

None of the three screws associated with this event were returned for evaluation.A photograph of one of the devices was provided, but the identifying information was not provided so it is unknown which of the three screws is in the photo.The photo confirmed the tulip disassembled from the shaft and the retaining ring moved within the tulip.However, the cause of the disassembly cannot be determined by reviewing the photo.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: CANNULATED POLYAXIAL SCREW 4.5MM X 30MM
• 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: 6829758
• MDR Text Key: 83962058
• Report Number: 3012447612-2017-00435
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: PK132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 3505-4530
• Device Lot Number: 83QQ
• Other Device ID Number: (01)00889024335561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2014
• 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