MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL HEX SCREW DRIVER (2.5MM); SCREWDRIVER

Catalog Number	07.01764.002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.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 the tip of the virage poly-axial screwdriver broke while positioning during a cervical fixation at c4.The broken piece was retrieved with a pair of surgical tweezers and the procedure was completed with another driver.There was no patient impact.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in d4: udi number, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation the returned device matches the information in the complaint file and was examined.Visual inspection revealed the tip has fractured off see images attached in the sub-form.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review per dhr review, the part was likely conforming when it left zimvie control.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 the tip of the virage poly-axial screwdriver broke while positioning during a cervical fixation at c4.The broken piece was retrieved with a pair of surgical tweezers and the procedure was completed with another driver.There was no patient impact.
Additional Manufacturer Narrative
Corrections in h6.Device evaluation the returned device matches the information in the complaint file and was examined.Visual inspection revealed the tip has fractured off with a regular torsion fracture pattern.Potential cause this event could possibly be attributed to excessive torsional forces applied during use, possibly when placing a screw in hard bone or after improper screw hole preparation.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.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 the tip of the virage poly-axial screwdriver broke while positioning during a cervical fixation at c4.The broken piece was retrieved with a pair of surgical tweezers and the procedure was completed with another driver.There was no patient impact.

• Brand Name: POLYAXIAL HEX SCREW DRIVER (2.5MM)
• Common Device Name: SCREWDRIVER
• 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: 16973857
• Report Number: 3012447612-2023-00167
• Device Sequence Number: 20492912
• Product Code: HXX
• UDI-Device Identifier: 00887868289095
• UDI-Public: (01)00887868289095(10)63359075
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2025

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: Other
• Device Catalogue Number: 07.01764.002
• Device Lot Number: 63359075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 04/27/2023; Not provided
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 11/10/2023; 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic