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

Catalog Number 3301-1

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2022

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 report 3012447612-2022-00267.

Event Description

It was reported that five sequoia closure tops stripped while being final tightened intra-operatively.Other closure tops were used to complete the procedure.There was a delay of about 30 minutes, but there were no patient impacts.This is report one of five for this event.

Manufacturer Narrative

Corrections in d4: udi number, d9, and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation : visual inspection revealed no clear damage to any of the hex drives.Visual inspection revealed that 3 of the closure tops had damaged threads, but 2 closure tops did not (lot: abg).Potential cause: root cause was unable to be determined.This event could possibly be attributed to off-axis forces applied during closure top insertion, cross-threading, or using a stripped driver.Dhr review per dhr review, the parts were likely conforming when they left zimvie control.Device use this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

Event Description

It was reported that five sequoia closure tops stripped while being final tightened intra-operatively.Other closure tops were used to complete the procedure.There was a delay of about 30 minutes, but there were no patient impacts.This is report one of five for this event.

• Brand Name: OPEN IMPLANT CLOSURE TOP, 5.5MM, 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
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 15831038
• MDR Text Key: 305685280
• Report Number: 3012447612-2022-00263
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024334861
• UDI-Public: (01)00889024334861(10)ABF
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K131980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2022
• 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: ABF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female