MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 6.5 X 50MM MULTIAXIAL SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number 2000-2450

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 12/02/2021

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 3012447612-2021-00478 through 3012447612-2021-00480.

Event Description

It was reported that during surgery, three multi-axial screw heads jammed so they lost their polyaxial motion.New screws were used to complete the case without patient impacts.This is report one of three for this event.

Event Description

It was reported that during surgery, three multi-axial screw heads jammed so they lost their polyaxial motion.New screws were used to complete the case without patient impacts.This is report one of three for this event.

Manufacturer Narrative

Device evaluation: functional inspection revealed that each screw was unable to maintain polyaxial movement without significant jamming/sticking.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown events during handling or use.Dhr review: per dhr review, the parts were likely conforming when they 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.

• Brand Name: 6.5 X 50MM MULTIAXIAL SCREW
• Type of Device: EBI 5.5 HELICAL FLANGE SPINAL 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: 13062900
• MDR Text Key: 282716714
• Report Number: 3012447612-2021-00478
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00888480207764
• UDI-Public: (01)00888480207764(10)J6757459
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061441
• 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: 2000-2450
• Device Lot Number: J6757459
• 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: 12/02/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2020
• 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 Age: 44 YR
• Patient Sex: Male
• Patient Weight: 75 KG