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
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11680443
• Report Number: 3012447612-2021-00122
• Device Sequence Number: 4168615
• Product Code: MNH
• UDI-Device Identifier: 00880304925182
• UDI-Public: (01)00880304925182(10)J6482766
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2021

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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 63