MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. OPEN-OPEN SADDLE PARALLEL DOMINO 5.5 X 5.5MM, 0 DEG; POLARIS SPINAL SYSTEM

Catalog Number	14-589607
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Two polaris 4.75 dominos were returned with the pieces reported on 3012447612-2022-00086 through 3012447612-2022-00095, and were also found to have damaged threads.There were no reported patient impacts.This is report two of two for this event.
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference report 3012447612-2022-00157.
Event or Problem Description
Two polaris 4.75 dominos were returned with the pieces reported on 3012447612-2022-00086 through 3012447612-2022-00095, and were also found to have damaged threads.There were no reported patient impacts.This is report two of two for this event.
Additional Manufacturer Narrative
Device evaluation: visual inspection revealed damage to the threading of all the returned devices.There was no damage to the screw drives.Root cause: root cause was unable to be determined.This event could possibly be attributed to inserting the closure tops off-axis and cross threading them, and then continuing to attempt installation on cross-threaded screws.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: OPEN-OPEN SADDLE PARALLEL DOMINO 5.5 X 5.5MM, 0 DEG
• Common Device Name: POLARIS 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: 14732708
• Report Number: 3012447612-2022-00158
• Device Sequence Number: 11316129
• Product Code: NKB
• UDI-Device Identifier: 00880304926189
• UDI-Public: (01)00880304926189(10)3072011
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K133746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 14-589607
• Device Lot Number: 3072011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown