MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 8.5MM X 80MM MULTIAXIAL ILIAC SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number 14-500334

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluation: the tulip and the supports for the pedicle screw have been returned; the shaft and supports disassembled from the tulip.The threaded shaft was not returned, likely since it was reported to remain implanted within the patient.Potential cause root cause was unable to be determined.Potential root causes for screw disassembly include pressure and off-axis forces applied to the tulip head causing the retaining rings to deform and allow the tulip head to come off of the screw.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.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 3012447612-2021-00315 through 3012447612-2021-00317.

Event Description

It was reported that the tips of two screw inserters broke intra-op while attempting to remove previously implanted iliac screws.During the removal of one of the screws, the tulip detached from the threaded shaft and the surgeon was unable to remove the threaded shaft so it remains implanted.This is report two of three for this event.

• Brand Name: 8.5MM X 80MM MULTIAXIAL ILIAC 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: 12385947
• MDR Text Key: 268738599
• Report Number: 3012447612-2021-00316
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-500334
• Device Lot Number: J3026183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2013
• 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