MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL SCREW (DIA. 4.0 MM X 20 MM L); APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	07.01702.056
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.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.
Event or Problem Description
It was reported that a virage tulip broke off the shank of the screw at c1 as the surgeon was operating.They were able to retrieve the screw and revise to a larger diameter screw.There was no patient impact; however, there was a 20 minute delay while the screw was removed and replaced.
Additional Manufacturer Narrative
Corrections in d4: lot & udi number, d9, and h3.Additional information in h4.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that a virage tulip broke off the shank of the screw at c1 as the surgeon was operating.They were able to retrieve the screw and revise to a larger diameter screw.There was no patient impact; however, there was a 20 minute delay while the screw was removed and replaced.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun (02)" no longer applies but cannot be removed.Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Inspection the returned device was examined.Visual inspection revealed the screw shank has fractured.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to excessive torque applied to the screw during implantation.Device usage this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported that a virage tulip broke off the shank of the screw at c1 as the surgeon was operating.They were able to retrieve the screw and revise to a larger diameter screw.There was no patient impact; however, there was a 20 minute delay while the screw was removed and replaced.

• Brand Name: POLYAXIAL SCREW (DIA. 4.0 MM X 20 MM L)
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 21095972
• Report Number: 3012447612-2025-00016
• Device Sequence Number: 21066649
• Product Code: KWP
• UDI-Device Identifier: 00889024327498
• UDI-Public: (01)00889024327498(10)AAT
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K133556
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2025

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: 07.01702.056
• Device Lot Number: AAT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/29/2025; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic