MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SEQUOIA OPEN CLOSURE, 5.5M, TOP TI; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

Catalog Number 3301-1

Device Problem Material Deformation (2976)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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.Reference report 3012447612-2020-00450.

Event Description

It was reported that two sequoia closure tops were found to have thread damage during incoming part inspections.Therefore, no surgical or patient information is available.This is report two of two for this event.

Event Description

It was reported that two sequoia closure tops were found to have thread damage during incoming part inspections.Therefore, no surgical or patient information is available.This is report two of two for this event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Inspection the product number and lot number of the devices were confirmed to match the complaint file.Visual investigation of the closure tops revealed that the threads are stripped.The complaint is confirmed.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.Complaint history: see (b)(4) for a review of the complaint history for this issue.Potential root cause as this failure is regularly occurring with known causes and impacts, a more thorough investigation has been documented and can be found in (b)(4).This evaluation provides a full analysis of potential causes based on testing performed by the engineering department, a review of the ifu and stg, as well as an analysis of the failure rates, severities and overall risk evaluations for a time period greater than the standard 12 month evaluation based on rmf-sp0028-0059.As this etm is being referenced, the failure that has occurred in this event does not exceed the severity identified and is associated with the failure being assessed in the etm.Per the etm, the cross threading/stripping can often occur due to misalignment of the screw head on the extender sleeve.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: SEQUOIA OPEN CLOSURE, 5.5M, TOP TI
• 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
• MDR Report Key: 10410977
• MDR Text Key: 203153581
• Report Number: 3012447612-2020-00451
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K131980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3301-1
• Device Lot Number: AAR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1