MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. EXTENDER SLEEVE, REDUCTION STYLE, LONG; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number 3557-2300

Device Problem Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2017

Event Type  malfunction  

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 3012447612-2017-00458, and 3012447612-2017-00461.

Event Description

It was reported that the screw interface on three extender sleeves is starting to wear.This occurred outside of surgery so did not have any surgical or patient impacts.This is report two of three for this event.

Manufacturer Narrative

The returned sleeve was evaluated.The threads which connect to the mating pedicle screw tulip were found to be deformed and the sleeve legs splayed.The sleeve would not attached to a mating pedicle screw during a functional evaluation.The cause can likely be attributed to misalignment with the tulip heads of the mating polyaxial screws when trying to attach the sleeves to the tulip heads.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: EXTENDER SLEEVE, REDUCTION STYLE, LONG
• 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: 6835269
• MDR Text Key: 84814973
• Report Number: 3012447612-2017-00460
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 3557-2300
• Device Lot Number: 83BE
• Other Device ID Number: (01)00889024336346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1