MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. UNKNOWN POLARIS 5.5 SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/18/2022

Event Type  Injury  

Event Description

It was reported that during a surgery to remove previously-implanted hardware at the patient's request, the tips of five drivers broke while attempting to remove the final iliac screw.The first eleven screws were successfully removed, but the twelfth screw could not be removed so the tulip was detached and removed, leaving the screw shaft in place.There was a delay associated with attempting to remove the final screw, but there were no impacts associated with the delay.This is report six of six for this event.

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 3012447612-2022-00254 through 3012447612-2022-00259.

Manufacturer Narrative

Component, investigation type, findings, and conclusions.Device evaluation: screw was not returned, so device evaluation could not be completed for the screw.Root cause: root cause was unable to be determined.Dhr review: dhr review unable to be completed for the screw as product information is not known.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 during a surgery to remove previously-implanted hardware at the patient's request, the tips of five drivers broke while attempting to remove the final iliac screw.The first eleven screws were successfully removed, but the twelfth screw could not be removed so the tulip was detached and removed, leaving the screw shaft in place.There was a delay associated with attempting to remove the final screw, but there were no impacts associated with the delay.This is report six of six for this event.

• Brand Name: UNKNOWN POLARIS 5.5 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: 15780695
• MDR Text Key: 303555655
• Report Number: 3012447612-2022-00259
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Male