MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. MODULAR HANDLE, T NON-RATCHETING TLR 90 IN-LBS; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number 3572-2

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2018

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.

Event Description

It was reported that the torque output of a torque limiting handle was found outside of the adequate performance range.This was detected during a preliminary calibration check.There are no specific surgical procedures associated with this handle.

Manufacturer Narrative

Udi number: na.Additional information: method, results, and conclusions - the returned device was evaluated.The torque output was confirmed to be outside of the range.There were no signs of abnormal wear found.Handles found out of calibration typically exhibit spring relaxation, wear of critical torque components, and/or break down of the internal lubrication from use over time.A review of the manufacturing records did not identify any issues which may have contributed to this event.

Event Description

It was reported that the torque output of a torque limiting handle was found outside of the adequate performance range.This was detected during a preliminary calibration check.There are no specific surgical procedures associated with this handle.

• Brand Name: MODULAR HANDLE, T NON-RATCHETING TLR 90 IN-LBS
• 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: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 8026653
• MDR Text Key: 125775063
• Report Number: 3012447612-2018-00853
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 3572-2
• Device Lot Number: 77BQ-007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1