MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. MODULAR HANDLE, T NON-RATCHETING TORQUE LIMITING 90 IN-LB; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

Catalog Number 3356-2

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2018

Event Type  malfunction  

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.

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 by zimmer biomet spine personnel.There are no specific surgical procedures associated with this handle.

Manufacturer Narrative

Additional information: (ethnicity), (method, results, 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 by zimmer biomet spine personnel.There are no specific surgical procedures associated with this handle.

• Brand Name: MODULAR HANDLE, T NON-RATCHETING TORQUE LIMITING 90 IN-LB
• Type of Device: SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR 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: 7763242
• MDR Text Key: 116546328
• Report Number: 3012447612-2018-00559
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK131980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 3356-2
• Device Lot Number: 86KD-033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• 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