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 03/11/2022

Event Type  malfunction  

Event Description

It was reported that three pathfinder closure tops stripped during final tightening intra-operatively.They were removed and replaced with other closure tops to complete the procedure without patient impacts.This is report two of three for this event.

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 3012447612-2022-00083 through 3012447612-2022-00085.

Event Description

It was reported that three pathfinder closure tops stripped during final tightening intra-operatively.They were removed and replaced with other closure tops to complete the procedure without patient impacts.This is report two of three for this event.

Manufacturer Narrative

Device evaluation: visual inspection revealed no damage to either the hex drive or the threads.Potential cause: root cause was unable to be determined as no product issue was found.Dhr review: per dhr review, the parts were likely conforming when they left zimvie control.Device use: these devices are 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.

• 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: 13996699
• MDR Text Key: 288855733
• Report Number: 3012447612-2022-00084
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024334861
• UDI-Public: (01)00889024334861(10)ABD
• 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: 06/27/2022

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: Health Professional
• Device Catalogue Number: 3301-1
• Device Lot Number: ABD
• 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: 03/11/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2020
• 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: Male