MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 6.5 X 45MM MULTIAXIAL SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Model Number N/A

Device Problems Crack (1135); Mechanical Problem (1384)

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

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

The complaint is confirmed for one returned polaris screw for the failure of lacking polyaxial motion, causing mating issues.Medical records were not provided for review.Device evaluation: visual inspection revealed minor scratches on the tulip, but no signs of damage.A functional examination shows that the tulip is frozen and there is no polyaxial movement of the tulip head.The complaint is not confirmed for a crack, however it is confirmed for no polyaxial motion of the tulip head.Potential cause: root cause was unable to be determined.This event could possibly be attributed to forces applied at an off-axis angle.Dhr review and related actions: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use and compatibility: this device is used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported the polaris screw was found to have a crack at the end of the screw connection during the operation.Another screw was used to complete the operation.No patient impact was reported.However, upon device evaluation by the manufacturer, the screw was found to have lost its polyaxial motion.

• Brand Name: 6.5 X 45MM 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: 11680443
• MDR Text Key: 248174893
• Report Number: 3012447612-2021-00122
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00880304925182
• UDI-Public: (01)00880304925182(10)J6482766
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 2000-2445
• Device Lot Number: J6482766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2019
• 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 Weight: 63