MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CLOSURE TOP; 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 05/26/2023

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 reports 3012447612-2023-00191 through 3012447612-2023-00193.

Event Description

It was reported that three closure tops stripped during final tightening intra-operatively.The closure tops were removed and replaced with additional closure tops.There was a delay of 30 minutes, but there were no patient impacts.This is report two of three for this event.

Manufacturer Narrative

Device evaluation: visual inspection revealed damage related to stripping on both the screw drive and the threads.Root 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 part was likely conforming when it left zimvie control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

Event Description

It was reported that three closure tops stripped during final tightening intra-operatively.The closure tops were removed and replaced with additional closure tops.There was a delay of 30 minutes, but there were no patient impacts.This is report two of three for this event.

• Brand Name: CLOSURE TOP
• 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: 17105770
• MDR Text Key: 316944779
• Report Number: 3012447612-2023-00192
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024334861
• UDI-Public: (01)00889024334861(10)ABG
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K131980
• Exemption Number: 5645646
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 3301-1
• Device Lot Number: ABG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic